Vital™
2,355 catalogue numbers from 801M4520, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
2,355catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2020-01-27 |
| Record revised | 2025-07-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801M4520 | Cann Poly 4.5 x 20 mm | In distribution |
| 807M4540 | Cann Uni 4.5 x 40 mm | In distribution |
| 801M6585 | Cann Poly 6.5 x 85 mm | In distribution |
| 805M9050 | Cann Open Iliac 9.0 x 50 mm | In distribution |
| 808M7510 | Cann Uni Red 7.5 x 110 mm | In distribution |
| 804M1560 | Cann Poly Red 10.5 x 60 mm | In distribution |
| 813M7505 | Cann Ext Uni 7.5 x 105 mm | In distribution |
| 812M6521 | Cann Ext Iliac 6.5 x 120 mm | In distribution |
| 806M7045 | Cann Closed Iliac 7.0 x 45 mm | In distribution |
| 806M9540 | Cann Closed Iliac 9.5 x 40 mm | In distribution |
| 807M6590 | Cann Uni 6.5 x 90 mm | In distribution |
| 807M6565 | Cann Uni 6.5 x 65 mm | In distribution |
| 815M2135 | 6.0 Ti Rod Perc Crv 135 mm | In distribution |
| 813M5055 | Cann Ext Uni 5.0 x 55 mm | In distribution |
| 805M7035 | Cann Open Iliac 7.0 x 35 mm | In distribution |
| 815M1185 | 5.5 Ti Rod Perc Crv 185 mm | In distribution |
| 816M2185 | 6.0 Ccr Rod Perc Crv 185 mm | In distribution |
| 816M3095 | 5.5 Ccr Rod Perc Str 95 mm | In distribution |
| 806M8030 | Cann Closed Iliac 8.0 x 30 mm | In distribution |
| 812M6510 | Cann Ext Iliac 6.5 x 110 mm | In distribution |
| 805M7545 | Cann Open Iliac 7.5 x 45 mm | In distribution |
| 808M5030 | Cann Uni Red 5.0 x 30 mm | In distribution |
| 809M5535 | Cann Mono 5.5 x 35 mm | In distribution |
| 810M6575 | Cann Poly Ext 6.5 x 75 mm | In distribution |
| 812M1021 | Cann Ext Iliac 10.0 x 120 mm | In distribution |
| 812M8045 | Cann Ext Iliac 8.0 x 45 mm | In distribution |
| 809M1540 | Cann Mono 10.5 x 40 mm | In distribution |
| 815M1100 | 5.5 Ti Rod Perc Crv 100 mm | In distribution |
| 807M7005 | Cann Uni 7.0 x 105 mm | In distribution |
| 805M1221 | Cann Open Iliac 11.5 x 120 mm | In distribution |
| 813M5060 | Cann Ext Uni 5.0 x 60 mm | In distribution |
| 813M7525 | Cann Ext Uni 7.5 x 25 mm | In distribution |
| 803M7020 | Cann Poly Red 7.0 x 20 mm | In distribution |
| 812M9575 | Cann Ext Iliac 9.5 x 75 mm | In distribution |
| 804M8035 | Cann Poly Red 8.0 x 35 mm | In distribution |
| 807M7565 | Cann Uni 7.5 x 65 mm | In distribution |
| 808M7521 | Cann Uni Red 7.5 x 120 mm | In distribution |
| 812M9590 | Cann Ext Iliac 9.5 x 90 mm | In distribution |
| 804M8580 | Cann Poly Red 8.5 x 80 mm | In distribution |
| 801M5535 | Cann Poly 5.5 x 35 mm | In distribution |
| 807M6530 | Cann Uni 6.5 x 30 mm | In distribution |
| 801M7555 | Cann Poly 7.5 x 55 mm | In distribution |
| 806M1121 | Cann Closed Iliac 11.0 x 120 mm | In distribution |
| 812M1040 | Cann Ext Iliac 10.0 x 40 mm | In distribution |
| 802M8015 | Cann Poly 8.0 x 115 mm | In distribution |
| 808M7055 | Cann Uni Red 7.0 x 55 mm | In distribution |
| 804M1525 | Cann Poly Red 10.5 x 25 mm | In distribution |
| 804M1095 | Cann Poly Red 10.0 x 95 mm | In distribution |
| 805M8585 | Cann Open Iliac 8.5 x 85 mm | In distribution |
| 806M6565 | Cann Closed Iliac 6.5 x 65 mm | In distribution |
| 811M8560 | Cann Poly Ext 8.5 x 60 mm | In distribution |
| 809M6525 | Cann Mono 6.5 x 25 mm | In distribution |
| 809M1530 | Cann Mono 10.5 x 30 mm | In distribution |
| 805M8525 | Cann Open Iliac 8.5 x 25 mm | In distribution |
| 815M3110 | 5.5 Ti Rod Perc Str 110 mm | In distribution |
| 815M4155 | 6.0 Ti Rod Perc Str 155 mm | In distribution |
| 805M9510 | Cann Open Iliac 9.5 x 110 mm | In distribution |
| 804M9535 | Cann Poly Red 9.5 x 35 mm | In distribution |
| 805M6520 | Cann Open Iliac 6.5 x 20 mm | In distribution |
| 806M7055 | Cann Closed Iliac 7.0 x 55 mm | In distribution |
| 804M9095 | Cann Poly Red 9.0 x 95 mm | In distribution |
| 805M1575 | Cann Open Iliac 10.5 x 75 mm | In distribution |
| 802M1545 | Cann Poly 10.5 x 45 mm | In distribution |
| 802M9570 | Cann Poly 9.5 x 70 mm | In distribution |
| 802M8570 | Cann Poly 8.5 x 70 mm | In distribution |
| 808M5590 | Cann Uni Red 5.5 x 90 mm | In distribution |
| 801M5570 | Cann Poly 5.5 x 70 mm | In distribution |
| 805M7060 | Cann Open Iliac 7.0 x 60 mm | In distribution |
| 811M1570 | Cann Poly Ext 10.5 x 70 mm | In distribution |
| 811M9595 | Cann Poly Ext 9.5 x 95 mm | In distribution |
| 816M4125 | 6.0 Ccr Rod Perc Str 125 mm | In distribution |
| 804M8060 | Cann Poly Red 8.0 x 60 mm | In distribution |
| 806M7530 | Cann Closed Iliac 7.5 x 30 mm | In distribution |
| 803M7540 | Cann Poly Red 7.5 x 40 mm | In distribution |
| 809M6575 | Cann Mono 6.5 x 75 mm | In distribution |
| 815M3105 | 5.5 Ti Rod Perc Str 105 mm | In distribution |
| 806M9055 | Cann Closed Iliac 9.0 x 55 mm | In distribution |
| 815M4085 | 6.0 Ti Rod Perc Str 85 mm | In distribution |
| 815M2180 | 6.0 Ti Rod Perc Crv 180 mm | In distribution |
| 808M5515 | Cann Uni Red 5.5 x 115 mm | In distribution |
| 805M6535 | Cann Open Iliac 6.5 x 35 mm | In distribution |
| 810M6030 | Cann Poly Ext 6.0 x 30 mm | In distribution |
| 813M6075 | Cann Ext Uni 6.0 x 75 mm | In distribution |
| 812M7050 | Cann Ext Iliac 7.0 x 50 mm | In distribution |
| 809M7080 | Cann Mono 7.0 x 80 mm | In distribution |
| 801M6545 | Cann Poly 6.5 x 45 mm | In distribution |
| 805M7540 | Cann Open Iliac 7.5 x 40 mm | In distribution |
| 802M1015 | Cann Poly 10.0 x 115 mm | In distribution |
| 807M6085 | Cann Uni 6.0 x 85 mm | In distribution |
| 803M6025 | Cann Poly Red 6.0 x 25 mm | In distribution |
| 804M9525 | Cann Poly Red 9.5 x 25 mm | In distribution |
| 806M7090 | Cann Closed Iliac 7.0 x 90 mm | In distribution |
| 809M1515 | Cann Mono 10.5 x 115 mm | In distribution |
| 809M8585 | Cann Mono 8.5 x 85 mm | In distribution |
| 815M1070 | 5.5 Ti Rod Perc Crv 70 mm | In distribution |
| 815M3145 | 5.5 Ti Rod Perc Str 145 mm | In distribution |
| 803M7585 | Cann Poly Red 7.5 x 85 mm | In distribution |
| 726M6450 | Rod, Ti, Ø3.5 mm to Ø6.0 mm, x 450 mm, Transition | In distribution |
| 812M7035 | Cann Ext Iliac 7.0 x 35 mm | In distribution |
| 805M7010 | Cann Open Iliac 7.0 x 110 mm | In distribution |
| 806M6521 | Cann Closed Iliac 6.5 x 120 mm | In distribution |
| 812M9500 | Cann Ext Iliac 9.5 x 100 mm | In distribution |
| 811M1090 | Cann Poly Ext 10.0 x 90 mm | In distribution |
| 805M8045 | Cann Open Iliac 8.0 x 45 mm | In distribution |
| 812M6540 | Cann Ext Iliac 6.5 x 40 mm | In distribution |
| 816M4090 | 6.0 Ccr Rod Perc Str 90 mm | In distribution |
| 803M7021 | Cann Poly Red 7.0 x 120 mm | In distribution |
| 850M1075 | Vital™ MIS Cannulated Tap 7.5 mm | In distribution |
| 806M1275 | Cann Closed Iliac 11.5 x 75 mm | In distribution |
| 815M1105 | 5.5 Ti Rod Perc Crv 105 mm | In distribution |
| 805M9045 | Cann Open Iliac 9.0 x 45 mm | In distribution |
| 803M7521 | Cann Poly Red 7.5 x 120 mm | In distribution |
| 809M1505 | Cann Mono 10.5 x 105 mm | In distribution |
| 815M1060 | 5.5 Ti Rod Perc Crv 60 mm | In distribution |
| 804M9065 | Cann Poly Red 9.0 x 65 mm | In distribution |
| 809M6070 | Cann Mono 6.0 x 70 mm | In distribution |
| 810M5575 | Cann Poly Ext 5.5 x 75 mm | In distribution |
| 802M8560 | Cann Poly 8.5 x 60 mm | In distribution |
| 815M3040 | 5.5 Ti Rod Perc Str 40 mm | In distribution |
| 809M6025 | Cann Mono 6.0 x 25 mm | In distribution |
| 813M4520 | Cann Ext Uni 4.5 x 20 mm | In distribution |
| 813M7035 | Cann Ext Uni 7.0 x 35 mm | In distribution |
| 806M8520 | Cann Closed Iliac 8.5 x 20 mm | In distribution |
| 812M6595 | Cann Ext Iliac 6.5 x 95 mm | In distribution |
| 806M7505 | Cann Closed Iliac 7.5 x 105 mm | In distribution |
| 810M7575 | Cann Poly Ext 7.5 x 75 mm | In distribution |
| 816M3040 | 5.5 Ccr Rod Perc Str 40 mm | In distribution |
| 805M1560 | Cann Open Iliac 10.5 x 60 mm | In distribution |
| 805M8095 | Cann Open Iliac 8.0 x 95 mm | In distribution |
| 809M6085 | Cann Mono 6.0 x 85 mm | In distribution |
| 802M8565 | Cann Poly 8.5 x 65 mm | In distribution |
| 803M6035 | Cann Poly Red 6.0 x 35 mm | In distribution |
| 813M7515 | Cann Ext Uni 7.5 x 115 mm | In distribution |
| 801M5020 | Cann Poly 5.0 x 20 mm | In distribution |
| 810M6555 | Cann Poly Ext 6.5 x 55 mm | In distribution |
| 803M4555 | Cann Poly Red 4.5 x 55 mm | In distribution |
| 804M8095 | Cann Poly Red 8.0 x 95 mm | In distribution |
| 809M1510 | Cann Mono 10.5 x 110 mm | In distribution |
| 810M4535 | Cann Poly Ext 4.5 x 35 mm | In distribution |
| 810M7050 | Cann Poly Ext 7.0 x 50 mm | In distribution |
| 813M5505 | Cann Ext Uni 5.5 x 105 mm | In distribution |
| 816M3070 | 5.5 Ccr Rod Perc Str 70 mm | In distribution |
| 805M8521 | Cann Open Iliac 8.5 x 120 mm | In distribution |
| 811M9030 | Cann Poly Ext 9.0 x 30 mm | In distribution |
| 816M2140 | 6.0 Ccr Rod Perc Crv 140 mm | In distribution |
| 806M9570 | Cann Closed Iliac 9.5 x 70 mm | In distribution |
| 815M4130 | 6.0 Ti Rod Perc Str 130 mm | In distribution |
| 804M1570 | Cann Poly Red 10.5 x 70 mm | In distribution |
| 801M6050 | Cann Poly 6.0 x 50 mm | In distribution |
| 804M1080 | Cann Poly Red 10.0 x 80 mm | In distribution |
| 802M9505 | Cann Poly 9.5 x 105 mm | In distribution |
| 805M6525 | Cann Open Iliac 6.5 x 25 mm | In distribution |
| 805M8560 | Cann Open Iliac 8.5 x 60 mm | In distribution |
| 816M3090 | 5.5 Ccr Rod Perc Str 90 mm | In distribution |
| 804M9040 | Cann Poly Red 9.0 x 40 mm | In distribution |
| 809M5510 | Cann Mono 5.5 x 110 mm | In distribution |
| 816M1120 | 5.5 Ccr Rod Perc Crv 120 mm | In distribution |
| 805M8510 | Cann Open Iliac 8.5 x 110 mm | In distribution |
| 812M1500 | Cann Ext Iliac 10.5 x 100 mm | In distribution |
| 801M7095 | Cann Poly 7.0 x 95 mm | In distribution |
| 812M1070 | Cann Ext Iliac 10.0 x 70 mm | In distribution |
| 805M1295 | Cann Open Iliac 11.5 x 95 mm | In distribution |
| 810M7545 | Cann Poly Ext 7.5 x 45 mm | In distribution |
| 802M9015 | Cann Poly 9.0 x 115 mm | In distribution |
| 807M5575 | Cann Uni 5.5 x 75 mm | In distribution |
| 808M6555 | Cann Uni Red 6.5 x 55 mm | In distribution |
| 816M1070 | 5.5 Ccr Rod Perc Crv 70 mm | In distribution |
| 809M9550 | Cann Mono 9.5 x 50 mm | In distribution |
| 806M1570 | Cann Closed Iliac 10.5 x 70 mm | In distribution |
| 815M2020 | 6.0 Ti Rod Perc Crv 20 mm | In distribution |
| 801M6560 | Cann Poly 6.5 x 60 mm | In distribution |
| 811M9535 | Cann Poly Ext 9.5 x 35 mm | In distribution |
| 801M6555 | Cann Poly 6.5 x 55 mm | In distribution |
| 811M9530 | Cann Poly Ext 9.5 x 30 mm | In distribution |
| 810M7035 | Cann Poly Ext 7.0 x 35 mm | In distribution |
| 806M8580 | Cann Closed Iliac 8.5 x 80 mm | In distribution |
| 804M8535 | Cann Poly Red 8.5 x 35 mm | In distribution |
| 815M1145 | 5.5 Ti Rod Perc Crv 145 mm | In distribution |
| 802M9065 | Cann Poly 9.0 x 65 mm | In distribution |
| 803M6520 | Cann Poly Red 6.5 x 20 mm | In distribution |
| 807M7070 | Cann Uni 7.0 x 70 mm | In distribution |
| 808M6500 | Cann Uni Red 6.5 x 100 mm | In distribution |
| 805M7005 | Cann Open Iliac 7.0 x 105 mm | In distribution |
| 809M1595 | Cann Mono 10.5 x 95 mm | In distribution |
| 809M9005 | Cann Mono 9.0 x 105 mm | In distribution |
| 812M1570 | Cann Ext Iliac 10.5 x 70 mm | In distribution |
| 812M1045 | Cann Ext Iliac 10.0 x 45 mm | In distribution |
| 815M4190 | 6.0 Ti Rod Perc Str 190 mm | In distribution |
| 801M7585 | Cann Poly 7.5 x 85 mm | In distribution |
| 809M9545 | Cann Mono 9.5 x 45 mm | In distribution |
| 803M7045 | Cann Poly Red 7.0 x 45 mm | In distribution |
| 805M1095 | Cann Open Iliac 10.0 x 95 mm | In distribution |
| 809M7510 | Cann Mono 7.5 x 110 mm | In distribution |
| 816M3195 | 5.5 Ccr Rod Perc Str 195 mm | In distribution |
| 812M1105 | Cann Ext Iliac 11.0 x 105 mm | In distribution |
| 809M9080 | Cann Mono 9.0 x 80 mm | In distribution |
| 816M4095 | 6.0 Ccr Rod Perc Str 95 mm | In distribution |
| 805M9020 | Cann Open Iliac 9.0 x 20 mm | In distribution |
| 811M8010 | Cann Poly Ext 8.0 x 110 mm | In distribution |
| 803M7090 | Cann Poly Red 7.0 x 90 mm | In distribution |
| 805M1165 | Cann Open Iliac 11.0 x 65 mm | In distribution |
| 808M4555 | Cann Uni Red 4.5 x 55 mm | In distribution |
| 812M9525 | Cann Ext Iliac 9.5 x 25 mm | In distribution |
| 812M8005 | Cann Ext Iliac 8.0 x 105 mm | In distribution |
| 811M8050 | Cann Poly Ext 8.0 x 50 mm | In distribution |
| 813M5535 | Cann Ext Uni 5.5 x 35 mm | In distribution |
| 802M1521 | Cann Poly 10.5 x 120 mm | In distribution |
| 802M9545 | Cann Poly 9.5 x 45 mm | In distribution |
| 813M4545 | Cann Ext Uni 4.5 x 45 mm | In distribution |
| 809M6020 | Cann Mono 6.0 x 20 mm | In distribution |
| 811M8085 | Cann Poly Ext 8.0 x 85 mm | In distribution |
| 812M7500 | Cann Ext Iliac 7.5 x 100 mm | In distribution |
| 809M5575 | Cann Mono 5.5 x 75 mm | In distribution |
| 809M8010 | Cann Mono 8.0 x 110 mm | In distribution |
| 806M9070 | Cann Closed Iliac 9.0 x 70 mm | In distribution |
| 812M7555 | Cann Ext Iliac 7.5 x 55 mm | In distribution |
| 805M1000 | Cann Open Iliac 10.0 x 100 mm | In distribution |
| 726M2450 | Rod, Ti, Ø3.5 mm to Ø5.5 mm, x 450 mm, Transition | In distribution |
| 802M8080 | Cann Poly 8.0 x 80 mm | In distribution |
| 809M1555 | Cann Mono 10.5 x 55 mm | In distribution |
| 805M6540 | Cann Open Iliac 6.5 x 40 mm | In distribution |
| 804M8010 | Cann Poly Red 8.0 x 110 mm | In distribution |
| 803M5590 | Cann Poly Red 5.5 x 90 mm | In distribution |
| 816M1190 | 5.5 Ccr Rod Perc Crv 190 mm | In distribution |
| 802M9040 | Cann Poly 9.0 x 40 mm | In distribution |
| 816M1170 | 5.5 Ccr Rod Perc Crv 170 mm | In distribution |
| 803M5570 | Cann Poly Red 5.5 x 70 mm | In distribution |
| 803M7595 | Cann Poly Red 7.5 x 95 mm | In distribution |
| 806M8565 | Cann Closed Iliac 8.5 x 65 mm | In distribution |
| 815M4065 | 6.0 Ti Rod Perc Str 65 mm | In distribution |
| 802M9520 | Cann Poly 9.5 x 20 mm | In distribution |
| 802M8520 | Cann Poly 8.5 x 20 mm | In distribution |
| 803M4540 | Cann Poly Red 4.5 x 40 mm | In distribution |
| 809M5050 | Cann Mono 5.0 x 50 mm | In distribution |
| 809M8035 | Cann Mono 8.0 x 35 mm | In distribution |
| 810M7590 | Cann Poly Ext 7.5 x 90 mm | In distribution |
| 806M8595 | Cann Closed Iliac 8.5 x 95 mm | In distribution |
| 812M1090 | Cann Ext Iliac 10.0 x 90 mm | In distribution |
| 804M1535 | Cann Poly Red 10.5 x 35 mm | In distribution |
| 801M6090 | Cann Poly 6.0 x 90 mm | In distribution |
| 811M8070 | Cann Poly Ext 8.0 x 70 mm | In distribution |
| 812M9595 | Cann Ext Iliac 9.5 x 95 mm | In distribution |
| 813M7530 | Cann Ext Uni 7.5 x 30 mm | In distribution |
| 806M1040 | Cann Closed Iliac 10.0 x 40 mm | In distribution |
| 811M8525 | Cann Poly Ext 8.5 x 25 mm | In distribution |
| 813M5025 | Cann Ext Uni 5.0 x 25 mm | In distribution |
| 803M7005 | Cann Poly Red 7.0 x 105 mm | In distribution |
| 815M4135 | 6.0 Ti Rod Perc Str 135 mm | In distribution |
| 802M8010 | Cann Poly 8.0 x 110 mm | In distribution |
| 726M1600 | Rod, CoCr, Ø3.5 mm to Ø5.5 mm, x 600 mm, Transition | 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 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| 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 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls Naming This Product
24 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
| Zimmer, Inc. | UDI-DI | 2020-05-05 | Class II | Under Investigation by firm | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | 3235 total | 2022-07-15 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.