Bone Management
BMA Kit, Master-Pin/ Master-Core
3manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 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 |
| Dentalmaster (Xiamen) Medical Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| 510(k) | K201210 |
| Record published | 2022-07-08 |
| Record revised | 2025-07-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MSS10 10 | In distribution | ||
| MSS12 14 | In distribution | ||
| BMPPL | In distribution | ||
| BMA02 | In distribution | ||
| MSS10 14 | In distribution | ||
| MP20 | 10 | In distribution | |
| MSS12 4 | In distribution | ||
| MSS10 6 | In distribution | ||
| MSS12 10 | In distribution | ||
| MSS10 4 | In distribution | ||
| MSS12 12 | In distribution | ||
| MSS10 12 | In distribution | ||
| MSS12 6 | In distribution | ||
| BMA03 | In distribution | ||
| MSS12 8 | In distribution | ||
| MSS10 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 1,295 |
| Faico CMF System | Faico Medical, LLC | 540 |
| Neoface | Neoortho Produtos Ortopédicos S/A | 181 |
| CMF Visionare | Visionare LLC | 155 |
| Universal Mandible AXS | Stryker Leibinger Gmbh & Co. KG | 148 |
| Tandry CMF Plate System | Microware Precision Co., Ltd. | 140 |
| Screw, Fixation, Intraosseous | Synthes Gmbh | 132 |
| Level ONE CMF | KLS-Martin L.P. | 71 |
| MatrixMIDFACE | Synthes Gmbh | 65 |
| PlusDrive | Synthes Gmbh | 52 |
| Universal 2.0 MP AXS | Stryker Leibinger Gmbh & Co. KG | 51 |
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 49 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
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.