Screw, Fixation, Intraosseous
TI Multi-Vector Dstr PIN Clamp Ramus-Very Limited Bone Stock
3manufacturers in China registered for this device type
2catalogue 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 (U.S.A.) LP |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| 510(k) | K010690 |
| Record published | 2015-09-14 |
| Record revised | 2025-03-06 (version 7) |
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 | 2020-06-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD487.942 | Withdrawn | |
| SD487.941 | Withdrawn |
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
Recalls Naming This Product
4 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 (HQ), Inc. | 510(k) number | 2013-05-31 | Class II | Device Design | Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would no | 121 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Device Design | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. | 2 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Device Design | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. | 24 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Device Design | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. | 18 | 2015-08-31 |
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.