PlusDrive
1.5MM TI Cortex SCR SLF-Tpng With Plusdrive(TM) Recess 12MM
3manufacturers in China registered for this device type
52catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K162594 |
| Record published | 2015-09-14 |
| Record revised | 2024-06-19 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 400.274E | In distribution | ||
| 401.063 | 5 | In distribution | |
| 400.280E | In distribution | ||
| 400.474 | 5 | In distribution | |
| 400.282E | In distribution | ||
| 400.036E | In distribution | ||
| 400.286E | In distribution | ||
| 400.288E | In distribution | ||
| 401.042E | In distribution | ||
| 401.061E | In distribution | ||
| 400.276 | 5 | In distribution | |
| 401.064E | In distribution | ||
| 400.412E | In distribution | ||
| 400.034E | In distribution | ||
| 400.042E | In distribution | ||
| 401.062E | In distribution | ||
| 400.058E | In distribution | ||
| 400.276E | In distribution | ||
| 400.412 | 5 | In distribution | |
| 400.275E | In distribution | ||
| 400.454 | 5 | In distribution | |
| 400.044E | In distribution | ||
| 400.470E | In distribution | ||
| 400.054E | In distribution | ||
| 400.046E | In distribution | ||
| 400.456E | In distribution | ||
| 400.454E | In distribution | ||
| 400.280 | 5 | In distribution | |
| 400.055 | 5 | In distribution | |
| 401.065E | In distribution | ||
| 400.455 | 5 | In distribution | |
| 400.040E | In distribution | ||
| 401.041E | In distribution | ||
| 400.038 | 5 | In distribution | |
| 400.034 | 5 | In distribution | |
| 400.056 | 5 | In distribution | |
| 400.455E | In distribution | ||
| 400.035E | In distribution | ||
| 400.470 | 5 | In distribution | |
| 400.046 | 5 | In distribution | |
| 400.038E | In distribution | ||
| 400.056E | In distribution | ||
| 401.043E | In distribution | ||
| 400.288 | 5 | In distribution | |
| 400.278E | In distribution | ||
| 401.044E | In distribution | ||
| 400.284E | In distribution | ||
| 400.055E | In distribution | ||
| 401.061 | 5 | In distribution | |
| 400.048E | In distribution | ||
| 401.065 | 5 | In distribution | |
| 401.063E | 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 |
| Universal 2.0 MP AXS | Stryker Leibinger Gmbh & Co. KG | 51 |
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 49 |
| CMF | Southern Medical (PTY) Ltd | 37 |
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.