Vital Spinal Fixation System
Rod Connector, Side-Side, 4 Screw, Hybrid, 5.5/6.0mm X 5.5/6.0mm
15manufacturers in China registered for this device type
4,422catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-12-29 |
| Record revised | 2026-03-23 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 804M1550 | Device Size Text, specify—Cann Poly Red 10.5 x 50 mm | In distribution |
| 707M7590 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø7.5MM X 90MM | In distribution |
| 705M7045 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø7.0MM X 45MM | In distribution |
| 07.02047.103 | In distribution | |
| 708M5545 | Device Size Text, specify—MONOAXIAL SCREW, Ø5.5MM X 45MM | In distribution |
| 708M9595 | Device Size Text, specify—MONOAXIAL SCREW, Ø9.5MM X 95MM | In distribution |
| 802M9570 | Device Size Text, specify—Cann Poly 9.5 x 70 mm | In distribution |
| 803M7050 | Device Size Text, specify—Cann Poly Red 7.0 x 50 mm | In distribution |
| 812M8500 | Device Size Text, specify—Cann Ext Iliac 8.5 x 100 mm | In distribution |
| 812M9075 | Device Size Text, specify—Cann Ext Iliac 9.0 x 75 mm | In distribution |
| 803M7060 | Device Size Text, specify—Cann Poly Red 7.0 x 60 mm | In distribution |
| 704M6585 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø6.5MM X 85MM | In distribution |
| 708M8075 | Device Size Text, specify—MONOAXIAL SCREW, Ø8.0MM X 75MM | In distribution |
| 802M8050 | Device Size Text, specify—Cann Poly 8.0 x 50 mm | In distribution |
| 807M5040 | Device Size Text, specify—Cann Uni 5.0 x 40 mm | In distribution |
| 702M8595 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø8.5MM X 95MM | In distribution |
| 07.02042.076 | Device Size Text, specify—Uniplanar Screw, Ø6.5mm X 50mm | In distribution |
| 702M9021 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø9.0MM X 120MM | In distribution |
| 802M8095 | Device Size Text, specify—Cann Poly 8.0 x 95 mm | In distribution |
| 702M8050 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø8.0MM X 50MM | In distribution |
| 701M6090 | Device Size Text, specify—POLYAXIAL SCREW, Ø6.0MM X 90MM | In distribution |
| 812M1260 | Device Size Text, specify—Cann Ext Iliac 11.5 x 60 mm | In distribution |
| 07.02047.126 | In distribution | |
| 806M8540 | Device Size Text, specify—Cann Closed Iliac 8.5 x 40 mm | In distribution |
| 809M7510 | Device Size Text, specify—Cann Mono 7.5 x 110 mm | In distribution |
| 815M4080 | Device Size Text, specify—6.0 Ti Rod Perc Str 80 mm | In distribution |
| 706M6045 | Device Size Text, specify—UNIPLANAR SCREW, Ø6.0MM X 45MM | In distribution |
| 805M7045 | Device Size Text, specify—Cann Open Iliac 7.0 x 45 mm | In distribution |
| 07.02047.093 | In distribution | |
| 704M8515 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø8.5MM X 115MM | In distribution |
| 805M1280 | Device Size Text, specify—Cann Open Iliac 11.5 x 80 mm | In distribution |
| 812M1030 | Device Size Text, specify—Cann Ext Iliac 10.0 x 30 mm | In distribution |
| 707M7045 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø7.0MM X 45MM | In distribution |
| 802M1040 | Device Size Text, specify—Cann Poly 10.0 x 40 mm | In distribution |
| 806M7075 | Device Size Text, specify—Cann Closed Iliac 7.0 x 75 mm | In distribution |
| 807M6535 | Device Size Text, specify—Cann Uni 6.5 x 35 mm | In distribution |
| 806M1505 | Device Size Text, specify—Cann Closed Iliac 10.5 x 105 mm | In distribution |
| 703M7575 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø7.5MM X 75MM | In distribution |
| 806M9530 | Device Size Text, specify—Cann Closed Iliac 9.5 x 30 mm | In distribution |
| 07.02016.003 | Device Size Text, specify—Rod, CoCr Ø5.5mm X 510mm, Straight | In distribution |
| 815M5300 | Device Size Text, specify—5.5 Ti Rod Perc Str 300 mm | In distribution |
| 07.02048.030 | Device Size Text, specify—Transverse Connector, Fixed, 47mm Wide X Ø6.0mm | In distribution |
| 704M8000 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø8.0MM X 100MM | In distribution |
| 07.02021.009 | Device Size Text, specify—Rod, Ti Ø6.0mm X 60mm, Curved | In distribution |
| 802M8010 | Device Size Text, specify—Cann Poly 8.0 x 110 mm | In distribution |
| 07.02048.019 | Device Size Text, specify—Transverse Connector, Fixed, 25mm Wide X Ø6.0mm | In distribution |
| 704M7545 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø7.5MM X 45MM | In distribution |
| 709M8060 | Device Size Text, specify—POLYAXIAL SCREW, Ø8.0MM X 60MM | In distribution |
| 804M9000 | Device Size Text, specify—Cann Poly Red 9.0 x 100 mm | In distribution |
| 809M9055 | Device Size Text, specify—Cann Mono 9.0 x 55 mm | In distribution |
| 07.02026.053 | Device Size Text, specify—Lateral Offset Connector – Closed, R15°, 50mm | In distribution |
| 702M1515 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø10.5MM X 115MM | In distribution |
| 702M1021 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø10.0MM X 120MM | In distribution |
| 706M6515 | Device Size Text, specify—UNIPLANAR SCREW, Ø6.5MM X 115MM | In distribution |
| 805M6590 | Device Size Text, specify—Cann Open Iliac 6.5 x 90 mm | In distribution |
| 707M6040 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø6.0MM X 40MM | In distribution |
| 704M1021 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø10.0MM X 120MM | In distribution |
| 07.02004.168 | Device Size Text, specify—Polyaxial Screw, Ø8.5mm X 90mm | In distribution |
| 707M5505 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø5.5MM X 105MM | In distribution |
| 806M1195 | Device Size Text, specify—Cann Closed Iliac 11.0 x 95 mm | In distribution |
| 809M1085 | Device Size Text, specify—Cann Mono 10.0 x 85 mm | In distribution |
| 705M1521 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø10.5MM X 120MM | In distribution |
| 812M1585 | Device Size Text, specify—Cann Ext Iliac 10.5 x 85 mm | In distribution |
| 708M6065 | Device Size Text, specify—MONOAXIAL SCREW, Ø6.0MM X 65MM | In distribution |
| 706M4545 | Device Size Text, specify—UNIPLANAR SCREW, Ø4.5MM X 45MM | In distribution |
| 805M7070 | Device Size Text, specify—Cann Open Iliac 7.0 x 70 mm | In distribution |
| 815M1155 | Device Size Text, specify—5.5 Ti Rod Perc Crv 155 mm | In distribution |
| 07.02042.054 | In distribution | |
| 701M5525 | Device Size Text, specify—POLYAXIAL SCREW, Ø5.5MM X 25MM | In distribution |
| 704M9580 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø9.5MM X 80MM | In distribution |
| 809M1005 | Device Size Text, specify—Cann Mono 10.0 x 105 mm | In distribution |
| 807M5030 | Device Size Text, specify—Cann Uni 5.0 x 30 mm | In distribution |
| 702M9570 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø9.5MM X 70MM | In distribution |
| 702M1560 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø10.5MM X 60MM | In distribution |
| 07.02000.026 | Device Size Text, specify—Polyaxial Screw, Ø5.0mm X 55mm | In distribution |
| 07.02015.006 | Device Size Text, specify—Rod, Ti Ø5.5mm X 45mm, Curved | In distribution |
| 705M9025 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø9.0MM X 25MM | In distribution |
| 07.02047.027 | Device Size Text, specify—Uniplanar Reduction Screw, Ø5.0mm X 60mm | In distribution |
| 07.02047.116 | Device Size Text, specify—Uniplanar Reduction Screw, Ø7.5mm X 40mm | In distribution |
| 706M7045 | Device Size Text, specify—UNIPLANAR SCREW, Ø7.0MM X 45MM | In distribution |
| 709M1515 | Device Size Text, specify—POLYAXIAL SCREW, Ø10.5MM X 115MM | In distribution |
| 804M8050 | Device Size Text, specify—Cann Poly Red 8.0 x 50 mm | In distribution |
| 702M1510 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø10.5MM X 110MM | In distribution |
| 708M4030 | Device Size Text, specify—MONOAXIAL SCREW, Ø4.0MM X 30MM | In distribution |
| 708M7005 | Device Size Text, specify—MONOAXIAL SCREW, Ø7.0MM X 105MM | In distribution |
| 801M5595 | Device Size Text, specify—Cann Poly 5.5 x 95 mm | In distribution |
| 707M6015 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø6.0MM X 115MM | In distribution |
| 07.02026.039 | Device Size Text, specify—Lateral Offset Connector – Closed, L15°, 100mm | In distribution |
| 708M5585 | Device Size Text, specify—MONOAXIAL SCREW, Ø5.5MM X 85MM | In distribution |
| 704M7010 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø7.0MM X 110MM | In distribution |
| 07.02017.027 | Device Size Text, specify—Rod, CoCr Ø5.5mm X 150mm, Straight | In distribution |
| 805M7525 | Device Size Text, specify—Cann Open Iliac 7.5 x 25 mm | In distribution |
| 805M9550 | Device Size Text, specify—Cann Open Iliac 9.5 x 50 mm | In distribution |
| 07.02021.007 | Device Size Text, specify—Rod, Ti Ø6.0mm X 50mm, Curved | In distribution |
| 801M7535 | Device Size Text, specify—Cann Poly 7.5 x 35 mm | In distribution |
| 07.02048.027 | Device Size Text, specify—Transverse Connector, Fixed, 41mm Wide X Ø6.0mm | In distribution |
| 703M6575 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø6.5MM X 75MM | In distribution |
| 808M7585 | Device Size Text, specify—Cann Uni Red 7.5 x 85 mm | In distribution |
| 809M6021 | Device Size Text, specify—Cann Mono 6.0 x 120 mm | In distribution |
| 815M1110 | Device Size Text, specify—5.5 Ti Rod Perc Crv 110 mm | In distribution |
| 705M1215 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø11.5MM X 115MM | In distribution |
| 702M9540 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø9.5MM X 40MM | In distribution |
| 806M7090 | Device Size Text, specify—Cann Closed Iliac 7.0 x 90 mm | In distribution |
| 812M7500 | Device Size Text, specify—Cann Ext Iliac 7.5 x 100 mm | In distribution |
| 07.02024.010 | Device Size Text, specify—Rod, CoCr Ø6.0mm X 65mm, Curved | In distribution |
| 706M7585 | Device Size Text, specify—UNIPLANAR SCREW, Ø7.5MM X 85MM | In distribution |
| 704M6580 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø6.5MM X 80MM | In distribution |
| 805M9530 | Device Size Text, specify—Cann Open Iliac 9.5 x 30 mm | In distribution |
| 702M8075 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø8.0MM X 75MM | In distribution |
| 809M6030 | Device Size Text, specify—Cann Mono 6.0 x 30 mm | In distribution |
| 708M6020 | Device Size Text, specify—MONOAXIAL SCREW, Ø6.0MM X 20MM | In distribution |
| 07.02047.087 | In distribution | |
| 809M8040 | Device Size Text, specify—Cann Mono 8.0 x 40 mm | In distribution |
| 07.02042.055 | In distribution | |
| 705M8590 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø8.5MM X 90MM | In distribution |
| 709M1040 | Device Size Text, specify—POLYAXIAL SCREW, Ø10.0MM X 40MM | In distribution |
| 701M6050 | Device Size Text, specify—POLYAXIAL SCREW, Ø6.0MM X 50MM | In distribution |
| 708M9570 | Device Size Text, specify—MONOAXIAL SCREW, Ø9.5MM X 70MM | In distribution |
| 802M9545 | Device Size Text, specify—Cann Poly 9.5 x 45 mm | In distribution |
| 809M6520 | Device Size Text, specify—Cann Mono 6.5 x 20 mm | In distribution |
| 809M8035 | Device Size Text, specify—Cann Mono 8.0 x 35 mm | In distribution |
| 705M8021 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø8.0MM X 120MM | In distribution |
| 702M8070 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø8.0MM X 70MM | In distribution |
| 704M1180 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø11.0MM X 80MM | In distribution |
| 807M4545 | Device Size Text, specify—Cann Uni 4.5 x 45 mm | In distribution |
| 812M1555 | Device Size Text, specify—Cann Ext Iliac 10.5 x 55 mm | In distribution |
| 707M4530 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø4.5MM X 30MM | In distribution |
| 806M6575 | Device Size Text, specify—Cann Closed Iliac 6.5 x 75 mm | In distribution |
| 804M8560 | Device Size Text, specify—Cann Poly Red 8.5 x 60 mm | In distribution |
| 805M1215 | Device Size Text, specify—Cann Open Iliac 11.5 x 115 mm | In distribution |
| 806M9005 | Device Size Text, specify—Cann Closed Iliac 9.0 x 105 mm | In distribution |
| 07.02042.111 | In distribution | |
| 703M6585 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø6.5MM X 85MM | In distribution |
| 07.02004.158 | Device Size Text, specify—Polyaxial Screw, Ø8.5mm X 40mm | In distribution |
| 706M4560 | Device Size Text, specify—UNIPLANAR SCREW, Ø4.5MM X 60MM | In distribution |
| 801M4550 | Device Size Text, specify—Cann Poly 4.5 x 50 mm | In distribution |
| 806M8521 | Device Size Text, specify—Cann Closed Iliac 8.5 x 120 mm | In distribution |
| 07.02000.058 | In distribution | |
| 726M2450 | Device Size Text, specify—Rod, Ti, Ø3.5 mm to Ø5.5 mm, x 450 mm, Transition | In distribution |
| 804M9545 | Device Size Text, specify—Cann Poly Red 9.5 x 45 mm | In distribution |
| 701M5020 | Device Size Text, specify—POLYAXIAL SCREW, Ø5.0MM X 20MM | In distribution |
| 708M5060 | Device Size Text, specify—MONOAXIAL SCREW, Ø5.0MM X 60MM | In distribution |
| 07.02012.206 | Device Size Text, specify—Polyaxial Closed Iliac Screw, Ø9.5mm X 70mm | In distribution |
| 07.02015.036 | Device Size Text, specify—Rod, Ti Ø5.5mm X 195mm, Curved | In distribution |
| 705M9570 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø9.5MM X 70MM | In distribution |
| 706M6565 | Device Size Text, specify—UNIPLANAR SCREW, Ø6.5MM X 65MM | In distribution |
| 707M4525 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø4.5MM X 25MM | In distribution |
| 806M9095 | Device Size Text, specify—Cann Closed Iliac 9.0 x 95 mm | In distribution |
| 706M7540 | Device Size Text, specify—UNIPLANAR SCREW, Ø7.5MM X 40MM | In distribution |
| 703M6570 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø6.5MM X 70MM | In distribution |
| 07.02014.017 | Device Size Text, specify—Rod, Ti Ø5.5mm X 100mm, Straight | In distribution |
| 801M7515 | Device Size Text, specify—Cann Poly 7.5 x 115 mm | In distribution |
| 707M5515 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø5.5MM X 115MM | In distribution |
| 812M1170 | Device Size Text, specify—Cann Ext Iliac 11.0 x 70 mm | In distribution |
| 806M8585 | Device Size Text, specify—Cann Closed Iliac 8.5 x 85 mm | In distribution |
| 812M6555 | Device Size Text, specify—Cann Ext Iliac 6.5 x 55 mm | In distribution |
| 07.02040.118 | Device Size Text, specify—Monoaxial Screw, Ø7.5mm X 50mm | In distribution |
| 702M1015 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø10.0MM X 115MM | In distribution |
| 705M9590 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø9.5MM X 90MM | In distribution |
| 704M6500 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø6.5MM X 100MM | In distribution |
| 708M7590 | Device Size Text, specify—MONOAXIAL SCREW, Ø7.5MM X 90MM | In distribution |
| 805M6555 | Device Size Text, specify—Cann Open Iliac 6.5 x 55 mm | In distribution |
| 807M7525 | Device Size Text, specify—Cann Uni 7.5 x 25 mm | In distribution |
| 701M5595 | Device Size Text, specify—POLYAXIAL SCREW, Ø5.5MM X 95MM | In distribution |
| 805M1555 | Device Size Text, specify—Cann Open Iliac 10.5 x 55 mm | In distribution |
| 805M8080 | Device Size Text, specify—Cann Open Iliac 8.0 x 80 mm | In distribution |
| 705M8085 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø8.0MM X 85MM | In distribution |
| 805M7515 | Device Size Text, specify—Cann Open Iliac 7.5 x 115 mm | In distribution |
| 805M9535 | Device Size Text, specify—Cann Open Iliac 9.5 x 35 mm | In distribution |
| 07.02026.061 | Device Size Text, specify—Lateral Offset Connector – Closed, R15°, 100mm | In distribution |
| 815M3140 | Device Size Text, specify—5.5 Ti Rod Perc Str 140 mm | In distribution |
| 705M8595 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø8.5MM X 95MM | In distribution |
| 07.02014.019 | Device Size Text, specify—Rod, Ti Ø5.5mm X 110mm, Straight | In distribution |
| 07.02020.001 | Device Size Text, specify—Rod, Ti Ø6.0mm X 20mm, Straight | In distribution |
| 705M9545 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø9.5MM X 45MM | In distribution |
| 704M1550 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø10.5MM X 50MM | In distribution |
| 803M6065 | Device Size Text, specify—Cann Poly Red 6.0 x 65 mm | In distribution |
| 07.02000.032 | Device Size Text, specify—Polyaxial Screw, Ø5.5mm X 40mm | In distribution |
| 701M7590 | Device Size Text, specify—POLYAXIAL SCREW, Ø7.5MM X 90MM | In distribution |
| 708M8510 | Device Size Text, specify—MONOAXIAL SCREW, Ø8.5MM X 110MM | In distribution |
| 807M6000 | Device Size Text, specify—Cann Uni 6.0 x 100 mm | In distribution |
| 07.02042.038 | In distribution | |
| 07.02040.011 | Device Size Text, specify—Monoaxial Screw, Ø4.5mm X 25mm | In distribution |
| 705M6510 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø6.5MM X 110MM | In distribution |
| 803M6085 | Device Size Text, specify—Cann Poly Red 6.0 x 85 mm | In distribution |
| 809M1095 | Device Size Text, specify—Cann Mono 10.0 x 95 mm | In distribution |
| 703M6005 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø6.0MM X 105MM | In distribution |
| 808M6500 | Device Size Text, specify—Cann Uni Red 6.5 x 100 mm | In distribution |
| 07.02029.002 | Device Size Text, specify—Rod Connector – Axial, Closed, 2 Screw, 5.5/6.0mm X 3.5mm | In distribution |
| 809M8030 | Device Size Text, specify—Cann Mono 8.0 x 30 mm | In distribution |
| 801M6535 | Device Size Text, specify—Cann Poly 6.5 x 35 mm | In distribution |
| 07.02020.024 | Device Size Text, specify—Rod, Ti Ø6.0mm X 135mm, Straight | In distribution |
| 805M9085 | Device Size Text, specify—Cann Open Iliac 9.0 x 85 mm | In distribution |
| 807M5535 | Device Size Text, specify—Cann Uni 5.5 x 35 mm | In distribution |
| 815M1145 | Device Size Text, specify—5.5 Ti Rod Perc Crv 145 mm | In distribution |
| 703M6021 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø6.0MM X 120MM | In distribution |
| 07.02040.120 | Device Size Text, specify—Monoaxial Screw, Ø7.5mm X 60mm | In distribution |
| 704M1170 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø11.0MM X 70MM | In distribution |
| 803M7535 | Device Size Text, specify—Cann Poly Red 7.5 x 35 mm | In distribution |
| 707M7015 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø7.0MM X 115MM | In distribution |
| 815M2135 | Device Size Text, specify—6.0 Ti Rod Perc Crv 135 mm | In distribution |
| 809M7040 | Device Size Text, specify—Cann Mono 7.0 x 40 mm | In distribution |
| 07.02048.032 | Device Size Text, specify—Transverse Connector, Fixed, 51mm Wide X Ø6.0mm | In distribution |
| 701M5580 | Device Size Text, specify—POLYAXIAL SCREW, Ø5.5MM X 80MM | In distribution |
| 705M7015 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø7.0MM X 115MM | In distribution |
| 709M1090 | Device Size Text, specify—POLYAXIAL SCREW, Ø10.0MM X 90MM | In distribution |
| 805M1050 | Device Size Text, specify—Cann Open Iliac 10.0 x 50 mm | In distribution |
| 805M1105 | Device Size Text, specify—Cann Open Iliac 11.0 x 105 mm | In distribution |
| 812M8520 | Device Size Text, specify—Cann Ext Iliac 8.5 x 20 mm | In distribution |
| 805M1180 | Device Size Text, specify—Cann Open Iliac 11.0 x 80 mm | In distribution |
| 809M7535 | Device Size Text, specify—Cann Mono 7.5 x 35 mm | In distribution |
| 802M8021 | Device Size Text, specify—Cann Poly 8.0 x 120 mm | In distribution |
| 806M1295 | Device Size Text, specify—Cann Closed Iliac 11.5 x 95 mm | In distribution |
| 07.02040.258 | Device Size Text, specify—Monoaxial Screw, Ø10.5mm X 120mm | In distribution |
| 704M7090 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø7.0MM X 90MM | In distribution |
| 708M6555 | Device Size Text, specify—MONOAXIAL SCREW, Ø6.5MM X 55MM | In distribution |
| 812M1165 | Device Size Text, specify—Cann Ext Iliac 11.0 x 65 mm | In distribution |
| 812M7570 | Device Size Text, specify—Cann Ext Iliac 7.5 x 70 mm | In distribution |
| 801M5575 | Device Size Text, specify—Cann Poly 5.5 x 75 mm | In distribution |
| 07.02001.013 | Device Size Text, specify—Polyaxial Reduction Screw, Ø4.5mm X 35mm | In distribution |
| 07.02005.258 | Device Size Text, specify—Polyaxial Reduction Screw, Ø10.5mm X 120mm | In distribution |
| 808M6090 | Device Size Text, specify—Cann Uni Red 6.0 x 90 mm | In distribution |
| 07.02000.013 | Device Size Text, specify—Polyaxial Screw, Ø4.5mm X 35mm | In distribution |
| 702M9075 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø9.0MM X 75MM | In distribution |
| 704M7080 | Device Size Text, specify—POLYAXIAL OPEN ILIAC SCREW, Ø7.0MM X 80MM | In distribution |
| 801M5535 | Device Size Text, specify—Cann Poly 5.5 x 35 mm | In distribution |
| 802M9515 | Device Size Text, specify—Cann Poly 9.5 x 115 mm | In distribution |
| 808M6570 | Device Size Text, specify—Cann Uni Red 6.5 x 70 mm | In distribution |
| 07.02021.023 | Device Size Text, specify—Rod, Ti Ø6.0mm X 130mm, Curved | In distribution |
| 806M9070 | Device Size Text, specify—Cann Closed Iliac 9.0 x 70 mm | In distribution |
| 807M6510 | Device Size Text, specify—Cann Uni 6.5 x 110 mm | In distribution |
| 812M1221 | Device Size Text, specify—Cann Ext Iliac 11.5 x 120 mm | In distribution |
| 705M1085 | Device Size Text, specify—POLYAXIAL CLOSED ILIAC SCREW, Ø10.0MM X 85MM | In distribution |
| 808M7025 | Device Size Text, specify—Cann Uni Red 7.0 x 25 mm | In distribution |
| 07.02015.007 | Device Size Text, specify—Rod, Ti Ø5.5mm X 50mm, Curved | In distribution |
| 07.02042.064 | In distribution | |
| 709M1085 | Device Size Text, specify—POLYAXIAL SCREW, Ø10.0MM X 85MM | In distribution |
| 709M8520 | Device Size Text, specify—POLYAXIAL SCREW, Ø8.5MM X 20MM | In distribution |
| 803M7020 | Device Size Text, specify—Cann Poly Red 7.0 x 20 mm | In distribution |
| 809M7065 | Device Size Text, specify—Cann Mono 7.0 x 65 mm | In distribution |
| 07.02000.011 | Device Size Text, specify—Polyaxial Screw, Ø4.5mm X 25mm | In distribution |
| 808M5595 | Device Size Text, specify—Cann Uni Red 5.5 x 95 mm | In distribution |
| 809M6585 | Device Size Text, specify—Cann Mono 6.5 x 85 mm | In distribution |
| 707M5040 | Device Size Text, specify—UNIPLANAR REDUCTION SCREW, Ø5.0MM X 40MM | In distribution |
| 709M9560 | Device Size Text, specify—POLYAXIAL SCREW, Ø9.5MM X 60MM | In distribution |
| 805M9560 | Device Size Text, specify—Cann Open Iliac 9.5 x 60 mm | In distribution |
| 07.02014.035 | Device Size Text, specify—Rod, Ti Ø5.5mm X 190mm, Straight | In distribution |
| 802M1050 | Device Size Text, specify—Cann Poly 10.0 x 50 mm | In distribution |
| 806M9565 | Device Size Text, specify—Cann Closed Iliac 9.5 x 65 mm | In distribution |
| 702M9555 | Device Size Text, specify—POLYAXIAL REDUCTION SCREW, Ø9.5MM X 55MM | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
| Vital™ | Biomet Spine | 2,355 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253093 | 2025-12-17 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-16 | Class II | Nonconforming Material/Component | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indent | 3 | |
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2012-11-30 | Class II | Process control | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification | 1999 | 2015-05-22 |
| 2011-12-19 | Class II | Device Design | The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient. | 10 | 2015-03-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.