OssBuilder System
27 catalogue numbers from SM2W10129SB, listed by Osstem Implant Co., Ltd., South Korea, under Plate, Bone. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
27catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172354 |
| Record published | 2018-04-05 |
| Record revised | 2023-08-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM2W10129SB | In distribution | |
| SB3V209F | In distribution | |
| SM1W4109SB | In distribution | |
| SB3H207F | In distribution | |
| SM2W10127SB | In distribution | |
| SB3V207F | In distribution | |
| SM3W12127SB | In distribution | |
| SB3H209F | In distribution | |
| SM3W10129SB | In distribution | |
| SM2W797SB | In distribution | |
| SB3H1011F | In distribution | |
| SB3V1011F | In distribution | |
| SM2W12127SB | In distribution | |
| SM2W799SB | In distribution | |
| SM1W4107SB | In distribution | |
| SB3V107F | In distribution | |
| SB3H107F | In distribution | |
| SM1W487SB | In distribution | |
| SM3W12129SB | In distribution | |
| SM3W799SB | In distribution | |
| SM3W797SB | In distribution | |
| SM3W10127SB | In distribution | |
| SM2W12129SB | In distribution | |
| SB3V2011F | In distribution | |
| SB3V109F | In distribution | |
| SB3H2011F | In distribution | |
| SB3H109F | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172354 | 2018-03-26 |
| K130840 | 2013-09-18 |
| K120951 | 2012-10-03 |
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.