Orthros
Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 110mm Lg.
15manufacturers in China registered for this device type
704catalogue numbers in this listing
2510(k) clearances naming this product 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 | Camber Spine Technologies, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K133366 |
| Record published | 2015-10-26 |
| Record revised | 2025-07-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 25 to 180 mm; outer diameter 5.5 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ø7.5mm Polyaxial Pedicle Screw, 110mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 90mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg. | In distribution | |
| Ø4.5mm Monoaxial Pedicle Screw, 25mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 75mm Lg. | In distribution | |
| ORT-5540 | Length 40 mm | In distribution |
| Ø6.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Polyaxial Pedicle Screw, 40mm Lg. | In distribution | |
| ORT-8595CR | Length 95 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 65mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 60mm Lg. | In distribution | |
| CP-010-05 | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 95mm Lg. | In distribution | |
| Ø5.5mm Monoaxial Pedicle Screw, 25mm Lg. | In distribution | |
| Ø5.5mm Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| ORT-7550C | Length 50 mm | In distribution |
| ORT-8570R | Length 70 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 40mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 35mm Lg. | In distribution | |
| Ø6.5mm Polyaxial Pedicle Screw, 60mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 105mm Lg. | In distribution | |
| CP-002-02 | In distribution | |
| Ø4.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 110mm Lg. | In distribution | |
| ORT-7590 | Length 90 mm | In distribution |
| CP-010-02 | In distribution | |
| ORO-75100R | Outer Diameter 7.5 mm | In distribution |
| Ø5.5mm Monoaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 80mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| ORT-5540C | Length 40 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 30mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 65mm Lg. | In distribution | |
| ORT-75100CR | Length 100 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 95mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 100mm Lg. | In distribution | |
| ORT-6530CR | Length 30 mm | In distribution |
| Ø5.5mm Straight Rod, 30mm Lg. | In distribution | |
| ORT-7545C | Length 45 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 85mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 60mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 80mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| ORT-8535 | Length 35 mm | In distribution |
| Ø6.5mm Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 110mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| CP-009-65 | Length 110 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 60mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| ORT-8550C | Length 50 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 45mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. | In distribution | |
| ORT-6555CR | Length 55 mm | In distribution |
| Ø7.5mm Monoaxial Pedicle Screw, 100mm Lg. | In distribution | |
| ORT-85110 | Length 110 mm | In distribution |
| ORT-4535 | Length 35 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 50mm Lg. | In distribution | |
| Ø4.5mm Polyaxial Pedicle Screw, 40mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| ORT-7565 | Length 65 mm | In distribution |
| ORT-5540R | Length 40 mm | In distribution |
| CP-008-61 | Length 135 mm | In distribution |
| ORT-7580 | Length 80 mm | In distribution |
| Ø8.5mm Polyaxial Pedicle Screw, 85mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 160mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 110mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 100mm Lg. | In distribution | |
| Ø5.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. | In distribution | |
| ORT-7530R | Length 30 mm | In distribution |
| ORT-6535CR | Length 35 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 40mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 500mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 80mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 105mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 60mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg. | In distribution | |
| Ø4.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 40mm Lg. | In distribution | |
| ORT-8530C | Length 30 mm | In distribution |
| Ø8.5mm Polyaxial Pedicle Screw, 75mm Lg. | In distribution | |
| ORT-7545 | Length 45 mm | In distribution |
| Ø4.5mm Monoaxial Pedicle Screw, 45mm Lg. | In distribution | |
| CP-009-59 | Length 80 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 110mm Lg. | In distribution | |
| Ø6.5mm Monoaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 100mm Lg. | In distribution | |
| ORT-7560 | Length 60 mm | In distribution |
| ORT-7595CR | Length 95 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 70mm Lg. | In distribution | |
| ORT-8545C | Length 45 mm | In distribution |
| ORT-5550C | Length 50 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 95mm Lg. | In distribution | |
| ORO-7535R | Outer Diameter 7.5 mm | In distribution |
| ORT-8590CR | Length 90 mm | In distribution |
| Ø8.5mm Polyaxial Pedicle Screw, 105mm Lg. | In distribution | |
| ORT-5555C | Length 55 mm | In distribution |
| Ø5.5mm Straight Rod, 55mm Lg. | In distribution | |
| Ø4.5mm Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 85mm Lg. | In distribution | |
| CP-008-51 | Length 85 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 70mm Lg. | In distribution | |
| ORT-7540 | Length 40 mm | In distribution |
| ORT-75105C | Length 105 mm | In distribution |
| Ø6.5mm Polyaxial Pedicle Screw, 60mm Lg. | In distribution | |
| Ø4.5mm Monoaxial Pedicle Screw, 25mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 65mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. | In distribution | |
| Ø6.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| ORT-8585 | Length 85 mm | In distribution |
| Ø7.5mm Monoaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Reduction Pedicle Screw, 50mm Lg. | In distribution | |
| CP-008-35 | Length 130 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 85mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 35mm Lg. | In distribution | |
| ORT-8555R | Length 55 mm | In distribution |
| Ø4.5mm Monoaxial Pedicle Screw, 50mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 100mm Lg. | In distribution | |
| Ø4.5mm Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| ORT-8550CR | Length 50 mm | In distribution |
| Ø4.5mm Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 100mm Lg. | In distribution | |
| ORT-7555R | Length 55 mm | In distribution |
| Ø5.5mm Curved Rod, 180mm Lg. | In distribution | |
| ORT-6545C | Length 45 mm | In distribution |
| Ø5.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 70mm Lg. | In distribution | |
| ORT-8560 | Length 60 mm | In distribution |
| ORT-7550R | Length 50 mm | In distribution |
| Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 25mm Lg. | In distribution | |
| CP-010-06 | In distribution | |
| ORT-5535CR | Length 35 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø4.5mm Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| Ø6.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| ORO-7595R | Outer Diameter 7.5 mm | In distribution |
| ORT-8595 | Length 95 mm | In distribution |
| ORT-7585C | Length 85 mm | In distribution |
| Ø6.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| .Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 70mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 50mm Lg. | In distribution | |
| ORT-5525CR | Length 25 mm | In distribution |
| ORT-8580C | Length 80 mm | In distribution |
| ORT-7565C | Length 65 mm | In distribution |
| ORT-7565R | Length 65 mm | In distribution |
| ORT-6560CR | Length 60 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 105mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 95mm Lg. | In distribution | |
| Ø6.5mm Monoaxial Pedicle Screw, 60mm Lg. | In distribution | |
| ORT-6535R | Length 35 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 100mm Lg. | In distribution | |
| Ø6.5mm Monoaxial Pedicle Screw, 55mm Lg. | In distribution | |
| ORT-8530 | In distribution | |
| ORO-8555R | Ø8.5mm polyaxial reduction pedicle screw , 55mm lg | In distribution |
| ORT-4545 | Length 45 mm | In distribution |
| ORT-8550 | Length 50 mm | In distribution |
| ORT-8550R | Length 50 mm | In distribution |
| Locking Cap | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg. | In distribution | |
| ORT-5525R | Length 25 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. | In distribution | |
| ORT-8585R | Length 85 mm | In distribution |
| ORT-75100C | Length 100 mm | In distribution |
| ORT-6540C | Length 40 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 105mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| ORT-85105C | Length 105 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 55mm Lg. | In distribution | |
| ORT-5555 | Length 55 mm | In distribution |
| Ø7.5mm Monoaxial Pedicle Screw, 100mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Pedicle Screw, 25mm Lg. | In distribution | |
| ORT-75110 | Length 110 mm | In distribution |
| ORT-5540CR | Length 40 mm | In distribution |
| CP-008-53 | Length 95 mm | In distribution |
| Ø5.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. | In distribution | |
| ORT-8555 | Length 55 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 85mm Lg. | In distribution | |
| ORT-7555CR | Length 55 mm | In distribution |
| Ø8.5mm Polyaxial Pedicle Screw, 70mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 110mm Lg. | In distribution | |
| ORT-7550CR | Length 50 mm | In distribution |
| CP-009-73 | Length 150 mm | In distribution |
| CP-002-01 | In distribution | |
| CP-010-03 | In distribution | |
| ORT-5535 | In distribution | |
| ORT-8565C | Length 65 mm | In distribution |
| Ø5.5mm Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| Ø6.5mm Polyaxial Pedicle Screw, 40mm Lg. | In distribution | |
| CP-008-55 | Length 105 mm | In distribution |
| ORT-6545CR | Length 45 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg. | In distribution | |
| ORT-8545 | Length 45 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 50mm Lg. | In distribution | |
| ORT-7585CR | Length 85 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø5.5mm Straight Rod, 80mm Lg. | In distribution | |
| Ø5.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø5.5mm Monoaxial Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Monoaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 80mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 105mm Lg. | In distribution | |
| ORO-6560R | Outer Diameter 6.5 mm | In distribution |
| ORT-7550 | Length 50 mm | In distribution |
| CP-009-63 | Length 100 mm | In distribution |
| ORT-8580R | Length 80 mm | In distribution |
| ORT-85100CR | Length 100 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 60mm Lg. | In distribution | |
| CP-008-41 | Length 35 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 30mm Lg. | In distribution | |
| Ø6.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. | In distribution | |
| ORT-7570C | Length 70 mm | In distribution |
| Ø7.5mm Monoaxial Pedicle Screw, 105mm Lg. | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 65mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg. | In distribution | |
| Ø5.5mm Curved Rod, 85mm Lg. | In distribution | |
| ORO-7545R | Outer Diameter 7.5 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 100mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 45mm Lg. | In distribution | |
| ORT-5535R | Length 35 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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|---|---|---|
| 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 |
|---|---|
| K180980 | 2018-10-27 |
| K133366 | 2014-04-08 |
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.