Stainless Steel
Uniplanar Screw, Stainless Steel, 9.50mm x 90mm
11manufacturers in China registered for this device type
101catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 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 |
| Label carries | lot or batch number |
| Distribution end date | 2017-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-14-9590 | 9.50mm x 90mm | Withdrawn |
| 25-10-8575 | 8.50mm x 75mm | Withdrawn |
| 25-15-8535 | 8.50mm x 35mm | Withdrawn |
| 25-35-7530 | 7.50mm x 30mm | Withdrawn |
| 25-35-6545 | 6.50mm x 45mm | Withdrawn |
| 25-12-5545 | 5.50mm x 45mm | Withdrawn |
| 25-15-6525 | 6.50mm x 25mm | Withdrawn |
| 25-10-9545 | 9.50mm x 45mm | Withdrawn |
| 25-14-9545 | 9.50mm x 45mm | Withdrawn |
| 25-15-5550 | 5.50mm x 50mm | Withdrawn |
| 25-35-4550 | 4.75mm x 50mm | Withdrawn |
| 25-10-9595 | 9.50mm x 95mm | Withdrawn |
| 25-10-8565 | 8.50mm x 65mm | Withdrawn |
| 25-15-8565 | 8.50mm x 65mm | Withdrawn |
| 25-35-5560 | 5.50mm x 60mm | Withdrawn |
| 25-12-4045 | 4.00mm x 45mm | Withdrawn |
| 25-14-5565 | 5.50mm x 65mm | Withdrawn |
| 25-10-9525 | 9.50mm x 25mm | Withdrawn |
| 25-14-4565 | 4.50mm x 65mm | Withdrawn |
| 25-12-4575 | 4.75mm x 75mm | Withdrawn |
| 25-12-4525 | 4.75mm x 25mm | Withdrawn |
| 25-35-5530 | 5.50mm x 30mm | Withdrawn |
| 25-12-4595 | 4.75mm x 95mm | Withdrawn |
| 25-35-5550 | 5.50mm x 50mm | Withdrawn |
| 25-12-4585 | 4.75mm x 85mm | Withdrawn |
| 25-12-4085 | 4.00mm x 85mm | Withdrawn |
| 25-15-6555 | 6.50mm x 55mm | Withdrawn |
| 25-15-4020 | 4.00mm x 20mm | Withdrawn |
| 25-15-8585 | 8.50mm x 85mm | Withdrawn |
| 25-12-4025 | 4.00mm x 25mm | Withdrawn |
| 25-15-4060 | 4.00mm x 60mm | Withdrawn |
| 25-15-7530 | 7.50mm x 30mm | Withdrawn |
| 25-12-4535 | 4.75mm x 35mm | Withdrawn |
| 25-15-7560 | 7.50mm x 60mm | Withdrawn |
| 25-12-5575 | 5.50mm x 75mm | Withdrawn |
| 25-14-9535 | 9.50mm x 35mm | Withdrawn |
| 25-15-4040 | 4.00mm x 40mm | Withdrawn |
| 25-12-5525 | 5.50mm x 25mm | Withdrawn |
| 25-15-4560 | 4.75mm x 60mm | Withdrawn |
| 25-10-8595 | 8.50mm x 95mm | Withdrawn |
| 25-10-9585 | 9.50mm x 85mm | Withdrawn |
| 25-12-4075 | 4.00mm x 75mm | Withdrawn |
| 25-10-9575 | 9.50mm x 75mm | Withdrawn |
| 25-12-5595 | 5.50mm x 95mm | Withdrawn |
| 25-15-4540 | 4.75mm x 40mm | Withdrawn |
| 25-15-4050 | 4.00mm x 50mm | Withdrawn |
| 25-35-6555 | 6.50mm x 55mm | Withdrawn |
| 25-12-4055 | 4.00mm x 55mm | Withdrawn |
| 25-15-6565 | 6.50mm x 65mm | Withdrawn |
| 25-12-5535 | 5.50mm x 35mm | Withdrawn |
| 25-35-4540 | 4.75mm x 40mm | Withdrawn |
| 25-15-9560 | 9.50mm x 60mm | Withdrawn |
| 25-35-6565 | 6.50mm x 65mm | Withdrawn |
| 25-15-8595 | 8.50mm x 95mm | Withdrawn |
| 25-14-9525 | 9.50mm x 25mm | Withdrawn |
| 25-15-9530 | 9.50mm x 30mm | Withdrawn |
| 25-15-5530 | 5.50mm x 30mm | Withdrawn |
| 25-12-4545 | 4.75mm x 45mm | Withdrawn |
| 25-15-6535 | 6.50mm x 35mm | Withdrawn |
| 25-35-5540 | 5.50mm x 40mm | Withdrawn |
| 25-12-4095 | 4.00mm x 95mm | Withdrawn |
| 25-10-9535 | 9.50mm x 35mm | Withdrawn |
| 25-15-4550 | 4.75mm x 50mm | Withdrawn |
| 25-15-7550 | 7.50mm x 50mm | Withdrawn |
| 25-12-4565 | 4.75mm x 65mm | Withdrawn |
| 25-15-7570 | 7.50mm x 70mm | Withdrawn |
| 25-35-5520 | 5.50mm x 20mm | Withdrawn |
| 25-35-4530 | 4.75mm x 30mm | Withdrawn |
| 25-15-5560 | 5.50mm x 60mm | Withdrawn |
| 25-14-8540 | 8.50mm x 40mm | Withdrawn |
| 25-12-5565 | 5.50mm x 65mm | Withdrawn |
| 25-15-4530 | 4.75mm x 30mm | Withdrawn |
| 25-14-8530 | 8.50mm x 30mm | Withdrawn |
| 25-35-6525 | 6.50mm x 25mm | Withdrawn |
| 25-15-6545 | 6.50mm x 45mm | Withdrawn |
| 25-12-4555 | 4.75mm x 55mm | Withdrawn |
| 25-12-4035 | 4.00mm x 35mm | Withdrawn |
| 25-10-8555 | 8.50mm x 55mm | Withdrawn |
| 25-15-4030 | 4.00mm x 30mm | Withdrawn |
| 25-12-5555 | 5.50mm x 55mm | Withdrawn |
| 25-15-9540 | 9.50mm x 40mm | Withdrawn |
| 25-15-8545 | 8.50mm x 45mm | Withdrawn |
| 25-10-9565 | 9.50mm x 65mm | Withdrawn |
| 25-15-7590 | 7.50mm x 90mm | Withdrawn |
| 25-35-6535 | 6.50mm x 35mm | Withdrawn |
| 25-15-9550 | 9.50mm x 50mm | Withdrawn |
| 25-15-7580 | 7.50mm x 80mm | Withdrawn |
| 25-15-5540 | 5.50mm x 40mm | Withdrawn |
| 25-15-8555 | 8.50mm x 55mm | Withdrawn |
| 25-15-8575 | 8.50mm x 75mm | Withdrawn |
| 25-35-4560 | 4.75mm x 60mm | Withdrawn |
| 25-10-8585 | 8.50mm x 85mm | Withdrawn |
| 25-15-7540 | 7.50mm x 40mm | Withdrawn |
| 25-12-4065 | 4.00mm x 65mm | Withdrawn |
| 25-10-9555 | 9.50mm x 55mm | Withdrawn |
| 25-12-5585 | 5.50mm x 85mm | Withdrawn |
| 25-15-8525 | 8.50mm x 25mm | Withdrawn |
| 25-15-4520 | 4.75mm x 20mm | Withdrawn |
| 25-12-6525 | 6.50mm x 25mm | Withdrawn |
| 25-15-9570 | 9.50mm x 70mm | Withdrawn |
| 25-15-5520 | 5.50mm x 20mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.