Reform Ti Modular
Modular Ti Cannulated Screw Implant Kit - Std: 5.5 - 7.5 Ply (CoCr Rods)
11manufacturers in China registered for this device type
85catalogue numbers in this listing
1510(k) clearance
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer |
| 510(k) | K150856 |
| Record published | 2019-10-03 |
| Record revised | 2024-10-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-SK-7535 | In distribution | |
| 39-BK-0543 | In distribution | |
| 39-SK-9560 | In distribution | |
| 39-SK-8511 | In distribution | |
| 39-SC-0534 | In distribution | |
| 39-SK-1011 | In distribution | |
| 39-SK-7545 | In distribution | |
| 39-BK-0546 | In distribution | |
| 39-BK-0542 | In distribution | |
| 39-SC-0525 | In distribution | |
| 39-SK-8545 | In distribution | |
| 39-SK-6535 | In distribution | |
| 39-SK-5045 | In distribution | |
| 39-BK-0541 | In distribution | |
| 39-CL-0027 | In distribution | |
| 39-SK-5555 | In distribution | |
| 39-BK-0150 | In distribution | |
| 39-SK-8555 | In distribution | |
| 39-SK-4535 | In distribution | |
| 39-SK-5530 | In distribution | |
| 39-SK-7560 | In distribution | |
| 39-BK-0151 | In distribution | |
| 39-SK-1060 | In distribution | |
| 39-SK-1000 | In distribution | |
| 39-SK-1050 | In distribution | |
| 39-MT-0402 | In distribution | |
| 39-SK-1040 | In distribution | |
| 39-BK-0523 | In distribution | |
| 39-BK-0530 | In distribution | |
| 39-SK-8580 | In distribution | |
| 39-CL-0028 | In distribution | |
| 39-BK-0547 | In distribution | |
| 39-SC-0536 | In distribution | |
| 39-SK-6525 | In distribution | |
| 39-BK-0548 | In distribution | |
| 39-BK-0544 | In distribution | |
| 39-SK-8500 | In distribution | |
| 39-SK-7580 | In distribution | |
| 39-SK-7555 | In distribution | |
| 39-SK-7550 | In distribution | |
| 39-SK-8550 | In distribution | |
| 39-SK-7570 | In distribution | |
| 39-SK-9511 | In distribution | |
| 39-SC-0523 | In distribution | |
| 39-SK-9555 | In distribution | |
| 39-MT-0401 | In distribution | |
| 39-SK-6545 | In distribution | |
| 39-SK-4540 | In distribution | |
| 39-SC-0527 | In distribution | |
| 39-SK-9550 | In distribution | |
| 39-SC-0151 | In distribution | |
| 39-SK-6560 | In distribution | |
| 39-SK-5560 | In distribution | |
| 39-SB-8512 | In distribution | |
| 39-CL-0030 | In distribution | |
| 39-SK-1045 | In distribution | |
| 39-SC-0150 | In distribution | |
| 39-SK-8560 | In distribution | |
| 39-SB-7535 | In distribution | |
| 39-SK-8570 | In distribution | |
| 39-BK-0520 | In distribution | |
| 39-SK-1090 | In distribution | |
| 39-SK-9500 | In distribution | |
| 39-SC-0524 | In distribution | |
| 39-SB-8555 | In distribution | |
| 39-SK-1080 | In distribution | |
| 39-BK-0545 | In distribution | |
| 39-BK-0525 | In distribution | |
| 39-SK-9580 | In distribution | |
| 39-SC-0526 | In distribution | |
| 39-SK-9570 | In distribution | |
| 39-SK-1070 | In distribution | |
| 39-CL-0033 | In distribution | |
| 39-SK-9545 | In distribution | |
| 39-MT-0403 | In distribution | |
| 39-SK-7540 | In distribution | |
| 39-SK-1055 | In distribution | |
| 39-SC-0535 | In distribution | |
| 39-SK-6555 | In distribution | |
| 39-CL-0066 | In distribution | |
| 39-SK-5525 | In distribution | |
| 39-SK-8590 | In distribution | |
| 39-CL-0048 | In distribution | |
| 39-SK-1012 | In distribution | |
| 39-SK-7530 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150851 | 2015-06-04 |
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.