Reform Pedicle Screw System
Reform® Modular Pedicle Screw System Tulip Caddy (Standard & Reduction)
13manufacturers in China registered for this device type
221catalogue 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 | 2019-05-30 |
| 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 |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39-SC-0309 | In distribution | |
| 39-PA-9570 | In distribution | |
| 39-UP-5555 | In distribution | |
| 39-UP-6550 | In distribution | |
| 39-RU-8550 | In distribution | |
| 39-SC-0311 | In distribution | |
| 39-RP-7550 | In distribution | |
| 39-UP-6525 | In distribution | |
| 39-RU-7530 | In distribution | |
| 39-PA-7560 | In distribution | |
| 39-RP-9590 | In distribution | |
| 39-BK-0511 | In distribution | |
| 39-PA-5550 | In distribution | |
| 39-UP-6555 | In distribution | |
| 39-RU-5535 | In distribution | |
| 39-BK-0811 | In distribution | |
| 39-PA-8540 | In distribution | |
| 39-LC-5065 | In distribution | |
| 39-LC-5045 | In distribution | |
| 39-BK-0306 | In distribution | |
| 39-PA-9545 | In distribution | |
| 39-RP-4545 | In distribution | |
| 39-BK-0303 | In distribution | |
| 39-LT-5110 | In distribution | |
| 39-UP-7530 | In distribution | |
| 39-RP-6530 | In distribution | |
| 39-RU-7540 | In distribution | |
| 39-LC-5040 | In distribution | |
| 39-RP-7540 | In distribution | |
| 39-PA-4535 | In distribution | |
| 39-SC-0403 | In distribution | |
| 39-RU-8545 | In distribution | |
| 39-ST-5300 | In distribution | |
| 39-RP-8545 | In distribution | |
| 39-LC-5150 | In distribution | |
| 39-ST-5120 | In distribution | |
| 39-BK-0106 | In distribution | |
| 39-RP-4540 | In distribution | |
| 39-PA-5525 | In distribution | |
| 39-SC-0505 | In distribution | |
| 39-UP-7560 | In distribution | |
| 39-SC-0306 | In distribution | |
| 39-RP-8560 | In distribution | |
| 39-SC-0300 | In distribution | |
| 39-RP-4530 | In distribution | |
| 39-RP-7545 | In distribution | |
| 39-BK-0311 | In distribution | |
| 39-RU-6560 | In distribution | |
| 39-TH-0301 | In distribution | |
| 39-PA-4545 | In distribution | |
| 39-SC-0502 | In distribution | |
| 39-RP-9580 | In distribution | |
| 39-PA-5560 | In distribution | |
| 39-SC-0503 | In distribution | |
| 39-PA-8535 | In distribution | |
| 39-SC-0308 | In distribution | |
| 39-TH-0203 | In distribution | |
| 39-SC-5200 | In distribution | |
| 39-RU-6540 | In distribution | |
| 39-RP-6545 | In distribution | |
| 39-LO-0140 | In distribution | |
| 39-RP-5540 | In distribution | |
| 39-RU-4525 | In distribution | |
| 39-SC-0506 | In distribution | |
| 39-LT-5100 | In distribution | |
| 39-RP-4525 | In distribution | |
| 39-BK-0308 | In distribution | |
| 39-ST-5150 | In distribution | |
| 39-RP-9560 | In distribution | |
| 39-MT-0301 | In distribution | |
| 39-BK-0812 | In distribution | |
| 39-BK-0101 | In distribution | |
| 39-SC-0102 | In distribution | |
| 39-PA-6540 | In distribution | |
| 39-SC-5100 | In distribution | |
| 39-LC-5110 | In distribution | |
| 39-BK-0512 | In distribution | |
| 39-RU-6535 | In distribution | |
| 39-PA-6525 | In distribution | |
| 39-RP-5530 | In distribution | |
| 39-BK-0502 | In distribution | |
| 39-RU-5530 | In distribution | |
| 39-LT-5200 | In distribution | |
| 39-UP-7535 | In distribution | |
| 39-RU-7550 | In distribution | |
| 39-CC-0030 | In distribution | |
| 39-SC-5120 | In distribution | |
| 39-BK-0501 | In distribution | |
| 39-SC-5400 | In distribution | |
| 39-RP-8535 | In distribution | |
| 39-UP-6545 | In distribution | |
| 39-BK-0513 | In distribution | |
| 39-RU-4545 | In distribution | |
| 39-RP-9555 | In distribution | |
| 39-BK-0800 | In distribution | |
| 39-RP-7535 | In distribution | |
| 39-PA-6560 | In distribution | |
| 39-CC-0040 | In distribution | |
| 39-LT-5090 | In distribution | |
| 39-RP-6540 | In distribution | |
| 39-BK-0201 | In distribution | |
| 39-RP-5555 | In distribution | |
| 39-SC-0500 | In distribution | |
| 39-SC-0100 | In distribution | |
| 39-PA-5545 | In distribution | |
| 39-SC-0303 | In distribution | |
| 39-RP-6535 | In distribution | |
| 39-RU-5540 | In distribution | |
| 39-SC-0109 | In distribution | |
| 39-LC-5035 | In distribution | |
| 39-PA-6530 | In distribution | |
| 39-RP-9540 | In distribution | |
| 39-RU-4540 | In distribution | |
| 39-PA-7555 | In distribution | |
| 39-SC-0201 | In distribution | |
| 39-UP-7540 | In distribution | |
| 39-SC-0101 | In distribution | |
| 39-UP-6535 | In distribution | |
| 39-LT-5040 | In distribution | |
| 39-RU-7535 | In distribution | |
| 39-LC-5120 | In distribution | |
| 39-LT-5045 | In distribution | |
| 39-LC-5050 | In distribution | |
| 39-BK-0301 | In distribution | |
| 39-SC-0105 | In distribution | |
| 39-RP-8555 | In distribution | |
| 39-LT-5050 | In distribution | |
| 39-SC-0104 | In distribution | |
| 39-BK-0307 | In distribution | |
| 39-BK-0309 | In distribution | |
| 39-UP-5535 | In distribution | |
| 39-ST-5100 | In distribution | |
| 39-RP-7530 | In distribution | |
| 39-CC-0048 | In distribution | |
| 39-BK-0104 | In distribution | |
| 39-LT-5070 | In distribution | |
| 39-UP-5560 | In distribution | |
| 39-SC-5150 | In distribution | |
| 39-LC-5060 | In distribution | |
| 39-LC-5055 | In distribution | |
| 39-PA-6555 | In distribution | |
| 39-RP-8570 | In distribution | |
| 39-RP-8550 | In distribution | |
| 39-TH-0222 | In distribution | |
| 39-PA-9555 | In distribution | |
| 39-BK-0814 | In distribution | |
| 39-RU-5525 | In distribution | |
| 39-RP-6555 | In distribution | |
| 39-ST-5200 | In distribution | |
| 39-PA-7535 | In distribution | |
| 39-SC-0304 | In distribution | |
| 39-BK-0402 | In distribution | |
| 39-RU-6555 | In distribution | |
| 39-PA-8545 | In distribution | |
| 39-PA-8580 | In distribution | |
| 39-RU-7555 | In distribution | |
| 39-SC-0310 | In distribution | |
| 39-RU-4535 | In distribution | |
| 39-PA-5540 | In distribution | |
| 39-LC-5100 | In distribution | |
| 39-RU-5550 | In distribution | |
| 39-RU-8540 | In distribution | |
| 39-RP-6550 | In distribution | |
| 39-BK-0103 | In distribution | |
| 39-BK-0107 | In distribution | |
| 39-SC-5060 | In distribution | |
| 39-SC-0501 | In distribution | |
| 39-UP-5525 | In distribution | |
| 39-BK-0401 | In distribution | |
| 39-RU-6550 | In distribution | |
| 39-BK-0105 | In distribution | |
| 39-PA-9535 | In distribution | |
| 39-UP-7550 | In distribution | |
| 39-RP-5545 | In distribution | |
| 39-ST-5080 | In distribution | |
| 39-RP-5550 | In distribution | |
| 39-RU-5555 | In distribution | |
| 39-LT-5060 | In distribution | |
| 39-PA-4540 | In distribution | |
| 39-RU-5560 | In distribution | |
| 39-UP-6560 | In distribution | |
| 39-BK-0203 | In distribution | |
| 39-PA-6550 | In distribution | |
| 39-PA-5530 | In distribution | |
| 39-PA-9550 | In distribution | |
| 39-PA-5535 | In distribution | |
| 39-PA-9560 | In distribution | |
| 39-SC-0305 | In distribution | |
| 39-BK-0514 | In distribution | |
| 39-UP-5545 | In distribution | |
| 39-SC-0402 | In distribution | |
| 39-SC-0307 | In distribution | |
| 39-BK-0302 | In distribution | |
| 39-CC-0035 | In distribution | |
| 39-PA-5555 | In distribution | |
| 39-ST-5060 | In distribution | |
| 39-SC-5040 | In distribution | |
| 39-CC-0032 | In distribution | |
| 39-RP-8540 | In distribution | |
| 39-PA-7530 | In distribution | |
| 39-SC-0103 | In distribution | |
| 39-PA-4530 | In distribution | |
| 39-PA-8590 | In distribution | |
| 39-PA-6545 | In distribution | |
| 39-SC-5080 | In distribution | |
| 39-PA-6535 | In distribution | |
| 39-RP-8580 | In distribution | |
| 39-SC-0108 | In distribution | |
| 39-SC-0202 | In distribution | |
| 39-RU-5545 | In distribution | |
| 39-UP-6540 | In distribution | |
| 39-TH-0302 | In distribution | |
| 39-UP-6530 | In distribution | |
| 39-RP-9570 | In distribution | |
| 39-RU-4530 | In distribution | |
| 39-LT-5120 | In distribution | |
| 39-BK-0305 | In distribution | |
| 39-BK-0304 | In distribution | |
| 39-RU-7545 | In distribution | |
| 39-PA-8570 | In distribution | |
| 39-UP-4530 | 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.