Stainless Steel
Uniplanar Screws 6.35mm Sterilization Case Assembly
15manufacturers in China registered for this device type
131catalogue numbers in this listing
3recalls 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 | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2014-09-22 |
| Record revised | 2025-07-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2017-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSDF4DPIMP | Withdrawn | |
| 25-14-5520 | 5.50mm x 20mm | Withdrawn |
| 25-15-9555 | 9.50mm x 55mm | Withdrawn |
| 25-35-8575 | 8.50mm x 75mm | Withdrawn |
| 25-35-4055 | 4.00mm x 55mm | Withdrawn |
| 25-15-9535 | 9.50mm x 35mm | Withdrawn |
| 25-15-8530 | 8.50mm x 30mm | Withdrawn |
| 25-12-5590 | 5.50mm x 90mm | Withdrawn |
| 25-10-8580 | 8.50mm x 80mm | Withdrawn |
| 25-15-7545 | 7.50mm x 45mm | Withdrawn |
| 25-10-8590 | 8.50mm x 90mm | Withdrawn |
| 25-15-4055 | 4.00mm x 55mm | Withdrawn |
| 25-12-5560 | 5.50mm x 60mm | Withdrawn |
| 25-14-9540 | 9.50mm x 40mm | Withdrawn |
| 25-34-9595 | 9.50mm x 95mm | Withdrawn |
| 25-14-4035 | 4.00mm x 35mm | Withdrawn |
| 25-10-9520 | 9.50mm x 20mm | Withdrawn |
| 25-34-8530 | 8.50mm x 30mm | Withdrawn |
| 25-35-8525 | 8.50mm x 25mm | Withdrawn |
| 25-15-7565 | 7.50mm x 65mm | Withdrawn |
| 25-15-4045 | 4.00mm x 45mm | Withdrawn |
| 25-35-9560 | 9.50mm x 60mm | Withdrawn |
| 25-15-4525 | 4.75mm x 25mm | Withdrawn |
| 25-15-9545 | 9.50mm x 45mm | Withdrawn |
| 25-15-5525 | 5.50mm x 25mm | Withdrawn |
| 25-35-7570 | 7.50mm x 70mm | Withdrawn |
| 25-35-9580 | 9.50mm x 80mm | Withdrawn |
| 25-14-9585 | 9.50mm x 85mm | Withdrawn |
| 25-14-8525 | 8.50mm x 25mm | Withdrawn |
| 25-12-5540 | 5.50mm x 40mm | Withdrawn |
| 25-15-5555 | 5.50mm x 55mm | Withdrawn |
| 25-15-8580 | 8.50mm x 80mm | Withdrawn |
| 25-35-9570 | 9.50mm x 70mm | Withdrawn |
| 25-12-4020 | 4.00mm x 20mm | Withdrawn |
| 25-35-8595 | 8.50mm x 95mm | Withdrawn |
| 25-12-5570 | 5.50mm x 70mm | Withdrawn |
| 25-35-9590 | 9.50mm x 90mm | Withdrawn |
| 25-35-9530 | 9.50mm x 30mm | Withdrawn |
| 25-12-5530 | 5.50mm x 30mm | Withdrawn |
| 25-12-4570 | 4.75mm x 70mm | Withdrawn |
| 25-32-6530 | 6.50mm x 30mm | Withdrawn |
| 25-12-4050 | 4.00mm x 50mm | Withdrawn |
| 25-34-9575 | 9.50mm x 75mm | Withdrawn |
| 25-34-8550 | 8.50mm x 50mm | Withdrawn |
| 25-15-4565 | 4.75mm x 65mm | Withdrawn |
| 25-12-4580 | 4.75mm x 80mm | Withdrawn |
| 25-15-8550 | 8.50mm x 50mm | Withdrawn |
| 25-12-4540 | 4.75mm x 40mm | Withdrawn |
| 25-12-4530 | 4.75mm x 30mm | Withdrawn |
| 25-12-4520 | 4.75mm x 20mm | Withdrawn |
| 25-34-9535 | 9.50mm x 35mm | Withdrawn |
| 25-10-9570 | 9.50mm x 70mm | Withdrawn |
| 25-12-4080 | 4.00mm x 80mm | Withdrawn |
| 25-15-7575 | 7.50mm x 75mm | Withdrawn |
| 25-15-5535 | 5.50mm x 35mm | Withdrawn |
| 25-10-9540 | 9.50mm x 40mm | Withdrawn |
| 25-12-4070 | 4.00mm x 70mm | Withdrawn |
| 25-15-7525 | 7.50mm x 25mm | Withdrawn |
| 25-35-8535 | 8.50mm x 35mm | Withdrawn |
| SSDF2FXIMP | Withdrawn | |
| 25-12-5550 | 5.50mm x 50mm | Withdrawn |
| 25-15-6550 | 6.50mm x 50mm | Withdrawn |
| 25-12-4060 | 4.00mm x 60mm | Withdrawn |
| 25-35-4045 | 4.00mm x 45mm | Withdrawn |
| 25-34-8590 | 8.50mm x 90mm | Withdrawn |
| 25-14-4065 | 4.00mm x 65mm | Withdrawn |
| 25-12-4590 | 4.75mm x 90mm | Withdrawn |
| 25-15-9525 | 9.50mm x 25mm | Withdrawn |
| 25-14-8535 | 8.50mm x 35mm | Withdrawn |
| 25-10-9530 | 9.50mm x 30mm | Withdrawn |
| 25-10-9590 | 9.50mm x 90mm | Withdrawn |
| 25-15-6540 | 6.50mm x 40mm | Withdrawn |
| 25-15-7535 | 7.50mm x 35mm | Withdrawn |
| 25-15-8590 | 8.50mm x 90mm | Withdrawn |
| 25-14-9530 | 9.50mm x 30mm | Withdrawn |
| 25-15-5545 | 5.50mm x 45mm | Withdrawn |
| 25-15-4535 | 4.75mm x 35mm | Withdrawn |
| 25-15-4025 | 4.00mm x 25mm | Withdrawn |
| 25-12-4030 | 4.00mm x 30mm | Withdrawn |
| 25-35-4025 | 4.00mm x 25mm | Withdrawn |
| 25-12-4550 | 4.75mm x 50mm | Withdrawn |
| 25-12-6530 | 6.50mm x 30mm | Withdrawn |
| 25-10-9550 | 9.50mm x 50mm | Withdrawn |
| 25-35-4035 | 4.00mm x 35mm | Withdrawn |
| 25-35-7590 | 7.50mm x 90mm | Withdrawn |
| 25-34-8540 | 8.50mm x 40mm | Withdrawn |
| 25-10-9580 | 9.50mm x 80mm | Withdrawn |
| 25-15-4065 | 4.00mm x 65mm | Withdrawn |
| 25-35-4520 | 4.75mm x 20mm | Withdrawn |
| 25-15-4555 | 4.75mm x 55mm | Withdrawn |
| 25-14-8545 | 8.50mm x 45mm | Withdrawn |
| 25-34-9555 | 9.50mm x 55mm | Withdrawn |
| 25-34-9525 | 9.50mm x 25mm | Withdrawn |
| 25-15-6560 | 6.50mm x 60mm | Withdrawn |
| 25-10-8560 | 8.50mm x 60mm | Withdrawn |
| 25-15-8570 | 8.50mm x 70mm | Withdrawn |
| 25-15-4035 | 4.00mm x 35mm | Withdrawn |
| 25-35-8545 | 8.50mm x 45mm | Withdrawn |
| 25-34-9545 | 9.50mm x 45mm | Withdrawn |
| SSDF3PSIMP | Withdrawn | |
| 25-15-6530 | 6.50mm x 30mm | Withdrawn |
| 25-15-7595 | 7.50mm x 95mm | Withdrawn |
| 25-12-5580 | 5.50mm x 80mm | Withdrawn |
| 25-14-9595 | 9.50mm x 95mm | Withdrawn |
| 25-14-4045 | 4.00mm x 45mm | Withdrawn |
| 25-12-4040 | 4.00mm x 40mm | Withdrawn |
| 25-15-8560 | 8.50mm x 60mm | Withdrawn |
| 25-10-9560 | 9.50mm x 60mm | Withdrawn |
| 25-12-6520 | 6.50mm x 20mm | Withdrawn |
| 25-12-4560 | 4.75mm x 60mm | Withdrawn |
| 25-35-4060 | 4.00mm x 60mm | Withdrawn |
| 25-15-7585 | 7.50mm x 85mm | Withdrawn |
| 25-15-9565 | 9.50mm x 65mm | Withdrawn |
| 25-34-8570 | 8.50mm x 70mm | Withdrawn |
| 25-35-9550 | 9.50mm x 50mm | Withdrawn |
| 25-15-8540 | 8.50mm x 40mm | Withdrawn |
| 25-35-9540 | 9.50mm x 40mm | Withdrawn |
| 25-35-8555 | 8.50mm x 55mm | Withdrawn |
| 25-35-8565 | 8.50mm x 65mm | Withdrawn |
| 25-34-8560 | 8.50mm x 60mm | Withdrawn |
| 25-35-8585 | 8.50mm x 85mm | Withdrawn |
| 25-15-5565 | 5.50mm x 65mm | Withdrawn |
| 25-12-5520 | 5.50mm x 20mm | Withdrawn |
| 25-10-8570 | 8.50mm x 70mm | Withdrawn |
| 25-34-9585 | 9.50mm x 85mm | Withdrawn |
| 25-15-4545 | 4.75mm x 45mm | Withdrawn |
| 25-34-8580 | 8.50mm x 80mm | Withdrawn |
| 25-34-9565 | 9.50mm x 65mm | Withdrawn |
| 25-12-4090 | 4.00mm x 90mm | Withdrawn |
| 25-15-7555 | 7.50mm x 55mm | Withdrawn |
| 25-35-7580 | 7.50mm x 80mm | Withdrawn |
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
Recalls
3 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 |
|---|---|---|---|---|---|
| 2014-06-27 | Class II | Under Investigation by firm | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. | 4 units | 2014-09-16 |
| 2014-06-09 | Class II | Under Investigation by firm | Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not alig | 94 units | 2014-11-06 |
| 2014-01-22 | Class II | Manufacturing material removal | Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some co | 40 | 2014-12-17 |
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.