Orthosis, Spondylolisthesis Spinal Fixation
4.0MM TI Cancellous Bone Screw 5.0MM Head - Fully THRDD/16MM
13manufacturers in China registered for this device type
77catalogue numbers in this listing
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Synthes (U.S.A.) LP |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K113044 |
| Record published | 2015-09-14 |
| Record revised | 2025-07-02 (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 |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 497.164A | Withdrawn | |
| 298.318 | Withdrawn | |
| 04.651.670 | Withdrawn | |
| 298.403 | Withdrawn | |
| 04.633.304 | Withdrawn | |
| 299.272 | Withdrawn | |
| 497.874 | Withdrawn | |
| 299.268 | Withdrawn | |
| 298.770 | Withdrawn | |
| 298.173 | Withdrawn | |
| 02.300.003 | Withdrawn | |
| 298.308 | Withdrawn | |
| 04.650.003 | Withdrawn | |
| 04.651.640 | Withdrawn | |
| 298.332 | Withdrawn | |
| 298.404 | Withdrawn | |
| 298.867 | Withdrawn | |
| 298.879 | Withdrawn | |
| 497.871 | Withdrawn | |
| 298.251 | Withdrawn | |
| 298.765 | Withdrawn | |
| 299.274 | Withdrawn | |
| 298.125 | Withdrawn | |
| 298.037 | Withdrawn | |
| 298.830 | Withdrawn | |
| 298.869 | Withdrawn | |
| 299.215 | Withdrawn | |
| 04.651.710 | Withdrawn | |
| 297.876 | Withdrawn | |
| 04.631.075 | Withdrawn | |
| 298.277 | Withdrawn | |
| 299.216 | Withdrawn | |
| 298.172 | Withdrawn | |
| 299.278 | Withdrawn | |
| 04.631.045 | Withdrawn | |
| 298.405 | Withdrawn | |
| 298.415 | Withdrawn | |
| 298.321 | Withdrawn | |
| 409.016 | Withdrawn | |
| 04.650.002 | Withdrawn | |
| 298.424 | Withdrawn | |
| 04.651.690 | Withdrawn | |
| 499.452 | Withdrawn | |
| 299.293 | Withdrawn | |
| 04.633.307 | Withdrawn | |
| 298.048 | Withdrawn | |
| 497.875 | Withdrawn | |
| 04.616.185 | Withdrawn | |
| 299.276 | Withdrawn | |
| 298.863 | Withdrawn | |
| 497.185A | Withdrawn | |
| 298.660 | Withdrawn | |
| 409.014 | Withdrawn | |
| 02.620.203 | Withdrawn | |
| 299.204 | Withdrawn | |
| 298.193 | Withdrawn | |
| 299.234 | Withdrawn | |
| 298.220 | Withdrawn | |
| 04.631.502 | Withdrawn | |
| 298.175 | Withdrawn | |
| 298.426 | Withdrawn | |
| 298.383 | Withdrawn | |
| 298.035 | Withdrawn | |
| 02.300.000 | Withdrawn | |
| 298.183 | Withdrawn | |
| 299.267 | Withdrawn | |
| 298.418 | Withdrawn | |
| 298.416 | Withdrawn | |
| 299.263 | Withdrawn | |
| 299.269 | Withdrawn | |
| 298.860 | Withdrawn | |
| 497.187 | Withdrawn | |
| 298.410 | Withdrawn | |
| 497.184A | Withdrawn | |
| 298.429 | Withdrawn | |
| 298.205 | Withdrawn | |
| 497.138 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-07 | Class II | Use error | This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential | 757 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-07 | Class II | Use error | This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential | 745 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-06-18 | Class II | Labeling design | Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this | 1602 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2011-03-11 | Not classified | Labeling Change Control | Labeling Correction — The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolonga | 2014-12-18 |
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.