Reform Pedicle Screw System
Modular Polyaxial Bone Screw Ø10.5mm x 120mm
11manufacturers in China registered for this device type
167catalogue 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) | K130279 |
| Record published | 2019-05-14 |
| Record revised | 2025-11-20 (version 6) |
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-AA-0101 | In distribution | |
| 39-TH-0102 | In distribution | |
| 39-MU-6540 | In distribution | |
| 39-PA-1000 | In distribution | |
| 39-DA-0202 | In distribution | |
| 39-MS-6555 | In distribution | |
| 39-MU-5540 | In distribution | |
| 39-PA-5060 | In distribution | |
| 39-MS-5525 | In distribution | |
| 39-TH-0232 | In distribution | |
| 39-TH-0262 | In distribution | |
| 39-MU-4525 | In distribution | |
| 39-MS-8540 | In distribution | |
| 39-MS-9545 | In distribution | |
| 39-DT-5300 | In distribution | |
| 39-MU-5545 | In distribution | |
| 39-PA-1012 | In distribution | |
| 39-DC-5080 | In distribution | |
| 39-MS-1070 | In distribution | |
| 39-MS-1050 | In distribution | |
| 39-MS-7560 | In distribution | |
| 39-MU-5530 | In distribution | |
| 39-MS-1040 | In distribution | |
| 39-TH-0202 | In distribution | |
| 39-LO-0120 | In distribution | |
| 39-MS-6530 | In distribution | |
| 39-MU-4540 | In distribution | |
| 39-MS-7530 | In distribution | |
| 39-TH-0242 | In distribution | |
| 39-DT-5500 | In distribution | |
| 39-MS-6540 | In distribution | |
| 39-PA-1011 | In distribution | |
| 39-DA-0102 | In distribution | |
| 39-TH-0252 | In distribution | |
| 39-MS-8555 | In distribution | |
| 39-MS-7580 | In distribution | |
| 39-PA-9511 | In distribution | |
| 39-TH-0351 | In distribution | |
| 39-TH-0213 | In distribution | |
| 39-MS-7550 | In distribution | |
| 39-PA-7570 | In distribution | |
| 39-MS-1090 | In distribution | |
| 39-PA-8512 | In distribution | |
| 39-MU-7535 | In distribution | |
| 39-RP-1080 | In distribution | |
| 39-RP-1040 | In distribution | |
| 39-PA-9512 | In distribution | |
| 39-ST-5600 | In distribution | |
| 39-MS-7545 | In distribution | |
| 39-DC-5100 | In distribution | |
| 39-MU-4530 | In distribution | |
| 39-MS-8511 | In distribution | |
| 39-MS-4540 | In distribution | |
| 39-TH-0205 | In distribution | |
| 39-PA-5025 | In distribution | |
| 39-MS-1055 | In distribution | |
| 39-DC-5150 | In distribution | |
| 39-RP-1045 | In distribution | |
| 39-SC-5600 | In distribution | |
| 39-PA-8511 | In distribution | |
| 39-RP-1050 | In distribution | |
| 39-MS-8500 | In distribution | |
| 39-MU-4535 | In distribution | |
| 39-PA-5055 | In distribution | |
| 39-DC-5500 | In distribution | |
| 39-MU-7545 | In distribution | |
| 39-LO-0220 | In distribution | |
| 39-RP-1070 | In distribution | |
| 39-MS-6550 | In distribution | |
| 39-RP-9500 | In distribution | |
| 39-PA-7580 | In distribution | |
| 39-PA-5035 | In distribution | |
| 39-DC-5120 | In distribution | |
| 39-DT-5150 | In distribution | |
| 39-LO-0240 | In distribution | |
| 39-LO-0130 | In distribution | |
| 39-MS-5540 | In distribution | |
| 39-DC-5600 | In distribution | |
| 39-RP-1090 | In distribution | |
| 39-DA-0301 | In distribution | |
| 39-LO-0250 | In distribution | |
| 39-MS-4530 | In distribution | |
| 39-PA-1070 | In distribution | |
| 39-MU-6545 | In distribution | |
| 39-RP-7560 | In distribution | |
| 39-SC-5500 | In distribution | |
| 39-MS-5535 | In distribution | |
| 39-MU-4545 | In distribution | |
| 39-MU-7550 | In distribution | |
| 39-MS-8545 | In distribution | |
| 39-MU-5525 | In distribution | |
| 39-MS-9555 | In distribution | |
| 39-DT-5600 | In distribution | |
| 39-MU-7540 | In distribution | |
| 39-ST-5500 | In distribution | |
| 39-RP-1012 | In distribution | |
| 39-MS-9500 | In distribution | |
| 39-MS-9580 | In distribution | |
| 39-DA-0201 | In distribution | |
| 39-RP-1055 | In distribution | |
| 39-TH-0452 | In distribution | |
| 39-LS-0200 | In distribution | |
| 39-MU-6535 | In distribution | |
| 39-MS-1080 | In distribution | |
| 39-MS-6535 | In distribution | |
| 39-MS-5555 | In distribution | |
| 39-MS-8512 | In distribution | |
| 39-MS-6545 | In distribution | |
| 39-MS-8550 | In distribution | |
| 39-MS-6525 | In distribution | |
| 39-MS-7555 | In distribution | |
| 39-TH-0402 | In distribution | |
| 39-TH-0401 | In distribution | |
| 39-MT-0302 | In distribution | |
| 39-MS-4525 | In distribution | |
| 39-RP-9512 | In distribution | |
| 39-TH-0272 | In distribution | |
| 39-RP-9511 | In distribution | |
| 39-MS-9511 | In distribution | |
| 39-DA-0302 | In distribution | |
| 39-MS-9570 | In distribution | |
| 39-MS-1012 | In distribution | |
| 39-PA-1045 | In distribution | |
| 39-TH-0201 | In distribution | |
| 39-DA-0101 | In distribution | |
| 39-MS-6560 | In distribution | |
| 39-LO-0230 | In distribution | |
| 39-PA-1080 | In distribution | |
| 39-TH-0101 | In distribution | |
| 39-TH-0212 | In distribution | |
| 39-MU-5535 | In distribution | |
| 39-MS-4545 | In distribution | |
| 39-TH-0352 | In distribution | |
| 39-TH-0233 | In distribution | |
| 39-MS-8570 | In distribution | |
| 39-MS-9540 | In distribution | |
| 39-TH-0103 | In distribution | |
| 39-MS-8535 | In distribution | |
| 39-MS-5560 | In distribution | |
| 39-MS-5530 | In distribution | |
| 39-RP-8512 | In distribution | |
| 39-TH-0221 | In distribution | |
| 39-MS-1011 | In distribution | |
| 39-MS-1060 | In distribution | |
| 39-TH-0451 | In distribution | |
| 39-LS-0100 | In distribution | |
| 39-DC-5300 | In distribution | |
| 39-MU-6550 | In distribution | |
| 39-PA-8500 | In distribution | |
| 39-RP-1000 | In distribution | |
| 39-PA-1060 | In distribution | |
| 39-DC-5400 | In distribution | |
| 39-RP-1060 | In distribution | |
| 39-RP-8500 | In distribution | |
| 39-MU-5550 | In distribution | |
| 39-MS-9560 | In distribution | |
| 39-PA-1040 | In distribution | |
| 39-MS-5545 | In distribution | |
| 39-PA-5045 | In distribution | |
| 39-LO-0150 | In distribution | |
| 39-TH-0206 | In distribution | |
| 39-MS-1045 | In distribution | |
| 39-MS-7540 | In distribution | |
| 39-PA-1090 | In distribution | |
| 39-DT-5120 | In distribution | |
| 39-MS-5550 | In distribution | |
| 39-PA-5030 | 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.