Plate, Bone
2.0MM TI Sagittal Split Plate Straight LOW-PROFILE/4H/27MM
3manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Synthes (U.S.A.) LP |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| 510(k) | K021642 |
| Record published | 2015-09-14 |
| Record revised | 2025-06-09 (version 8) |
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 | 2020-07-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD447.198 | Withdrawn | |
| 395.72 | Withdrawn | |
| SD447.197 | Withdrawn | |
| SD447.200 | Withdrawn | |
| 395.76 | Withdrawn | |
| SD446.046 | Withdrawn | |
| SD446.042 | Withdrawn | |
| SD447.199 | Withdrawn | |
| SD446.050 | Withdrawn | |
| SD446.053 | Withdrawn | |
| 402.006 | Withdrawn | |
| SD446.055 | Withdrawn | |
| SD447.204 | Withdrawn | |
| SD446.041 | Withdrawn | |
| SD446.040 | Withdrawn | |
| SD447.203 | Withdrawn | |
| SD446.049 | Withdrawn | |
| SD446.054 | Withdrawn | |
| SD446.521 | Withdrawn | |
| SD447.202 | Withdrawn | |
| SD447.195 | Withdrawn | |
| 395.71 | Withdrawn | |
| SD447.187 | Withdrawn | |
| SD447.193 | Withdrawn | |
| SD446.048 | Withdrawn | |
| SD446.044 | Withdrawn | |
| SD447.191 | Withdrawn | |
| SD447.190 | Withdrawn | |
| SD447.192 | Withdrawn | |
| SD446.522 | Withdrawn | |
| SD446.045 | Withdrawn | |
| SD446.051 | Withdrawn | |
| 395.75 | Withdrawn | |
| SD447.055 | Withdrawn | |
| 487.965 | Withdrawn | |
| SD446.043 | Withdrawn | |
| SD447.188 | Withdrawn | |
| SD447.196 | Withdrawn | |
| SD447.053 | Withdrawn | |
| SD447.189 | Withdrawn | |
| SD446.101 | Withdrawn | |
| SD447.194 | Withdrawn | |
| SD446.047 | Withdrawn | |
| 487.964 | Withdrawn | |
| SD447.201 | Withdrawn | |
| SD446.052 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
Recalls Naming This Product
6 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) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 90 units | 2016-12-13 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 182 units | 2016-12-13 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 413 units | 2016-12-13 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 259 units | 2016-12-13 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 274 units | 2016-12-13 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-23 | Class II | Under Investigation by firm | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | 599 units | 2016-12-13 |
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.