Orthosis, Spinal Pedicle Fixation
SM TI Tall Body Lamina Hook Dual-Opng Frontal F/6.0MM Rods
13manufacturers in China registered for this device type
246catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K092929 |
| Record published | 2015-09-14 |
| Record revised | 2024-09-11 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.161.052 | In distribution | |
| 04.615.602 | In distribution | |
| 496.793 | In distribution | |
| 498.173 | In distribution | |
| 498.106 | In distribution | |
| 498.453 | In distribution | |
| 498.187 | In distribution | |
| 04.616.175 | In distribution | |
| 499.204 | In distribution | |
| 498.207 | In distribution | |
| 499.247 | In distribution | |
| 04.615.634 | In distribution | |
| 498.395 | In distribution | |
| 04.614.050 | In distribution | |
| 04.615.148 | In distribution | |
| 499.214 | In distribution | |
| 09.633.185 | In distribution | |
| 04.615.240 | In distribution | |
| 499.115 | In distribution | |
| 04.633.291 | In distribution | |
| 04.651.455 | In distribution | |
| 298.380 | In distribution | |
| 04.620.135 | In distribution | |
| 04.620.140 | In distribution | |
| 04.615.118 | In distribution | |
| 498.283 | In distribution | |
| 04.633.700 | In distribution | |
| 04.651.490 | In distribution | |
| 04.615.232 | In distribution | |
| 04.614.040 | In distribution | |
| 498.237 | In distribution | |
| 04.615.526 | In distribution | |
| 04.615.108 | In distribution | |
| 497.78 | In distribution | |
| 298.119 | In distribution | |
| 04.614.551 | In distribution | |
| 09.636.030 | In distribution | |
| 498.245 | In distribution | |
| 04.614.210 | In distribution | |
| 04.601.110 | In distribution | |
| 498.104 | In distribution | |
| 04.636.050 | In distribution | |
| 04.615.326 | In distribution | |
| 04.615.642 | In distribution | |
| 04.651.260 | In distribution | |
| 04.633.317 | In distribution | |
| 298.535 | In distribution | |
| 09.633.197 | In distribution | |
| 499.290 | In distribution | |
| 04.651.525 | In distribution | |
| 498.382 | In distribution | |
| 04.615.640 | In distribution | |
| 498.724 | In distribution | |
| 498.150 | In distribution | |
| 04.634.260 | In distribution | |
| 498.243 | In distribution | |
| 04.614.509 | In distribution | |
| 04.615.643 | In distribution | |
| 04.633.500 | In distribution | |
| 04.615.630 | In distribution | |
| SD498.135 | In distribution | |
| 499.265 | In distribution | |
| 498.645 | In distribution | |
| 498.195 | In distribution | |
| 04.651.445 | In distribution | |
| 09.633.371 | In distribution | |
| 04.161.024 | In distribution | |
| 498.339 | In distribution | |
| 498.924 | In distribution | |
| 04.614.330 | In distribution | |
| 04.651.325 | In distribution | |
| 04.615.018 | In distribution | |
| 298.287 | In distribution | |
| 04.614.522 | In distribution | |
| 04.615.136 | In distribution | |
| 499.277 | In distribution | |
| 499.203 | In distribution | |
| 04.634.290 | In distribution | |
| 498.407 | In distribution | |
| 498.396 | In distribution | |
| 498.199 | In distribution | |
| 04.615.114 | In distribution | |
| 04.601.208 | In distribution | |
| 04.615.242 | In distribution | |
| 04.601.108 | In distribution | |
| 04.615.146 | In distribution | |
| 499.275 | In distribution | |
| 04.634.285 | In distribution | |
| 498.873 | In distribution | |
| 498.282 | In distribution | |
| 04.615.566 | In distribution | |
| 498.871 | In distribution | |
| 04.616.700 | In distribution | |
| 04.651.065 | In distribution | |
| 04.615.511 | In distribution | |
| 498.139 | In distribution | |
| 04.615.539 | In distribution | |
| 04.615.138 | In distribution | |
| 04.616.225 | In distribution | |
| 04.634.240 | In distribution | |
| 04.614.038 | In distribution | |
| 498.239 | In distribution | |
| 04.651.055 | In distribution | |
| 04.614.224 | In distribution | |
| 04.615.012 | In distribution | |
| 04.651.075 | In distribution | |
| 04.161.051 | In distribution | |
| 04.614.120 | In distribution | |
| 498.881 | In distribution | |
| 04.614.508 | In distribution | |
| 498.419 | In distribution | |
| 04.651.050 | In distribution | |
| 498.044 | In distribution | |
| 498.179 | In distribution | |
| 04.651.040 | In distribution | |
| 04.614.008 | In distribution | |
| 04.633.191 | In distribution | |
| 298.281 | In distribution | |
| 499.220 | In distribution | |
| 04.634.375 | In distribution | |
| 498.332 | In distribution | |
| 498.719 | In distribution | |
| 04.614.114 | In distribution | |
| 498.939 | In distribution | |
| 04.615.536 | In distribution | |
| 04.614.248 | In distribution | |
| 04.633.282 | In distribution | |
| 04.601.210 | In distribution | |
| 04.636.080 | In distribution | |
| 04.622.315 | In distribution | |
| 498.660 | In distribution | |
| 04.633.002 | In distribution | |
| 498.194 | In distribution | |
| 298.635 | In distribution | |
| 498.328 | In distribution | |
| 04.614.642 | In distribution | |
| 04.651.265 | In distribution | |
| 04.614.208 | In distribution | |
| 04.615.318 | In distribution | |
| 499.270 | In distribution | |
| 04.615.512 | In distribution | |
| 497.794 | In distribution | |
| 04.615.538 | In distribution | |
| 498.330 | In distribution | |
| 04.614.240 | In distribution | |
| 09.633.192 | In distribution | |
| 09.636.085 | In distribution | |
| 499.227 | In distribution | |
| 04.614.525 | In distribution | |
| 04.615.040 | In distribution | |
| 499.279 | In distribution | |
| 04.614.501 | In distribution | |
| 498.869 | In distribution | |
| 04.601.118 | In distribution | |
| 04.615.520 | In distribution | |
| 498.726 | In distribution | |
| 499.287 | In distribution | |
| 498.867 | In distribution | |
| 04.615.564 | In distribution | |
| 498.287 | In distribution | |
| 04.614.112 | In distribution | |
| 498.422 | In distribution | |
| 04.614.020 | In distribution | |
| 04.601.206 | In distribution | |
| 498.417 | In distribution | |
| 498.204 | In distribution | |
| 04.615.218 | In distribution | |
| 498.775 | In distribution | |
| 04.636.055 | In distribution | |
| 04.633.370 | In distribution | |
| 298.540 | In distribution | |
| 498.492 | In distribution | |
| 04.616.180 | In distribution | |
| 04.651.430 | In distribution | |
| 04.614.232 | In distribution | |
| 04.614.028 | In distribution | |
| 498.705 | In distribution | |
| 498.020 | In distribution | |
| 04.633.003 | In distribution | |
| 04.615.320 | In distribution | |
| 04.615.567 | In distribution | |
| 04.614.326 | In distribution | |
| 04.615.637 | In distribution | |
| 04.614.244 | In distribution | |
| 496.781 | In distribution | |
| 04.161.030 | In distribution | |
| 498.281 | In distribution | |
| 298.381 | In distribution | |
| 04.615.655 | In distribution | |
| 498.188 | In distribution | |
| 04.636.045 | In distribution | |
| 298.244 | In distribution | |
| 498.683 | In distribution | |
| 04.614.334 | In distribution | |
| 04.651.485 | In distribution | |
| 499.237 | In distribution | |
| 498.405 | In distribution | |
| 04.633.001 | In distribution | |
| 02.622.316 | In distribution | |
| 496.772 | In distribution | |
| 04.615.612 | In distribution | |
| 04.615.532 | In distribution | |
| 04.615.324 | In distribution | |
| 498.410 | In distribution | |
| 09.633.194 | In distribution | |
| 498.158 | In distribution | |
| SD498.134 | In distribution | |
| 499.260 | In distribution | |
| 04.614.246 | In distribution | |
| 04.161.011 | In distribution | |
| 498.862 | In distribution | |
| 498.331 | In distribution | |
| 496.69 | In distribution | |
| 499.243 | In distribution | |
| 498.350 | In distribution | |
| SD04.600.016 | In distribution | |
| 04.651.560 | In distribution | |
| 04.634.325 | In distribution | |
| 499.262 | In distribution | |
| 04.614.560 | In distribution | |
| 04.633.190 | In distribution | |
| 04.615.034 | In distribution | |
| 499.206 | In distribution | |
| 298.288 | In distribution | |
| 09.633.195 | In distribution | |
| 04.614.026 | In distribution | |
| 09.633.501 | In distribution | |
| 498.402 | In distribution | |
| 04.614.505 | In distribution | |
| 04.614.234 | In distribution | |
| 498.412 | In distribution | |
| 498.530 | In distribution | |
| 498.456 | In distribution | |
| 04.615.528 | In distribution | |
| 04.615.236 | In distribution | |
| 499.268 | In distribution | |
| 04.614.745 | In distribution | |
| 04.161.002 | In distribution | |
| 04.614.048 | In distribution | |
| 04.614.750 | In distribution | |
| 04.615.214 | In distribution | |
| 04.615.046 | In distribution | |
| 09.631.030 | In distribution | |
| 298.630 | In distribution | |
| 498.047 | In distribution | |
| 498.046 | 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 |
|---|---|
| K010108 | 2001-06-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| 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.