Reform TI Pedicle Screw System
Cannulated Implant Kit: Std + Outlier Ply + Red (Ti)
13manufacturers in China registered for this device type
105catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Precision Spine, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K121172 |
| Record published | 2019-05-13 |
| Record revised | 2024-09-11 (version 3) |
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-TP-7545 | In distribution | |
| 39-BK-1703 | In distribution | |
| 39-TP-9570 | In distribution | |
| 39-BK-1702 | In distribution | |
| 39-TR-6535 | In distribution | |
| 39-TP-8550 | In distribution | |
| 39-BK-1704 | In distribution | |
| 39-BK-0706 | In distribution | |
| 39-TP-4545 | In distribution | |
| 39-BK-0721 | In distribution | |
| 39-SC-0111 | In distribution | |
| 39-TP-7530 | In distribution | |
| 39-BK-0701 | In distribution | |
| 39-TR-9570 | In distribution | |
| 39-TR-6560 | In distribution | |
| 39-TP-6540 | In distribution | |
| 39-TP-4530 | In distribution | |
| 39-TP-5545 | In distribution | |
| 39-BK-1706 | In distribution | |
| 39-TR-7530 | In distribution | |
| 39-TR-8500 | In distribution | |
| 39-TR-7555 | In distribution | |
| 39-TP-5530 | In distribution | |
| 39-TP-4525 | In distribution | |
| 39-TR-7535 | In distribution | |
| 39-TP-9590 | In distribution | |
| 39-TR-8550 | In distribution | |
| 39-TR-9540 | In distribution | |
| 39-TR-8590 | In distribution | |
| 39-TR-4545 | In distribution | |
| 39-TR-7560 | In distribution | |
| 39-TR-9555 | In distribution | |
| 39-TP-4535 | In distribution | |
| 39-TR-7545 | In distribution | |
| 39-TR-9545 | In distribution | |
| 39-TR-8580 | In distribution | |
| 39-SB-7530 | In distribution | |
| 39-TR-5545 | In distribution | |
| 39-TP-9550 | In distribution | |
| 39-TP-6545 | In distribution | |
| 39-SC-2775 | In distribution | |
| 39-SC-0110 | In distribution | |
| 39-TR-4525 | In distribution | |
| 39-TR-6550 | In distribution | |
| 39-TR-6555 | In distribution | |
| 39-TR-6530 | In distribution | |
| 39-SC-0112 | In distribution | |
| 39-TP-8560 | In distribution | |
| 39-TP-8500 | In distribution | |
| 39-TP-5560 | In distribution | |
| 39-TP-9555 | In distribution | |
| 39-TP-9500 | In distribution | |
| 39-SB-6555 | In distribution | |
| 39-TR-5530 | In distribution | |
| 39-TR-4535 | In distribution | |
| 39-TR-6525 | In distribution | |
| 39-TP-5535 | In distribution | |
| 39-TP-4540 | In distribution | |
| 39-TP-6560 | In distribution | |
| 39-TR-4530 | In distribution | |
| 39-BK-1721 | In distribution | |
| 39-TR-5550 | In distribution | |
| 39-TR-9590 | In distribution | |
| 39-TR-8545 | In distribution | |
| 39-TP-8555 | In distribution | |
| 39-BK-0708 | In distribution | |
| 39-BK-0705 | In distribution | |
| 39-SB-7580 | In distribution | |
| 39-TR-9580 | In distribution | |
| 39-SB-1040 | In distribution | |
| 39-SC-0114 | In distribution | |
| 39-SB-6535 | In distribution | |
| 39-BK-1701 | In distribution | |
| 39-TP-1080 | In distribution | |
| 39-BK-0707 | In distribution | |
| 39-TP-8535 | In distribution | |
| 39-TP-7535 | In distribution | |
| 39-TP-7560 | In distribution | |
| 39-SC-2785 | In distribution | |
| 39-TP-6555 | In distribution | |
| 39-SC-2745 | In distribution | |
| 39-SC-0113 | In distribution | |
| 39-TR-8555 | In distribution | |
| 39-TP-9540 | In distribution | |
| 39-TP-6530 | In distribution | |
| 39-TR-5555 | In distribution | |
| 39-BK-1708 | In distribution | |
| 39-BK-0704 | In distribution | |
| 39-TR-5540 | In distribution | |
| 39-TP-6550 | In distribution | |
| 39-TR-6545 | In distribution | |
| 39-BK-0702 | In distribution | |
| 39-TP-9545 | In distribution | |
| 39-TR-6540 | In distribution | |
| 39-TR-5535 | In distribution | |
| 39-TP-5550 | In distribution | |
| 39-TR-5525 | In distribution | |
| 39-TP-8540 | In distribution | |
| 39-SC-2765 | In distribution | |
| 39-TR-4540 | In distribution | |
| 39-SC-2755 | In distribution | |
| 39-TP-7540 | In distribution | |
| 39-BK-1707 | In distribution | |
| 39-TR-7540 | In distribution | |
| 39-TP-9580 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141397 | 2014-06-26 |
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.