Screw, Fixation, Intraosseous
TI Multi-Vector Dstr PIN Hldg Clamp/Ramus-Limited Bone Stock
3manufacturers in China registered for this device type
132catalogue 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) | K021642 |
| 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 |
|---|---|---|---|
| 401.154 | 5 | In distribution | |
| 447.147 | In distribution | ||
| 401.836 | In distribution | ||
| 401.310E | In distribution | ||
| 446.783 | In distribution | ||
| 400.853 | 5 | In distribution | |
| 400.853E | In distribution | ||
| 400.787E | In distribution | ||
| 447.548 | In distribution | ||
| 400.808.96 | In distribution | ||
| 401.306 | 5 | In distribution | |
| 487.938 | In distribution | ||
| 401.311E | In distribution | ||
| 446.799 | In distribution | ||
| 201.510 | In distribution | ||
| 202.828 | In distribution | ||
| 401.818 | In distribution | ||
| 201.808.98 | In distribution | ||
| 447.681 | In distribution | ||
| 487.973 | In distribution | ||
| 201.928 | 5 | In distribution | |
| 400.701 | In distribution | ||
| 401.812.96 | In distribution | ||
| 400.789 | 5 | In distribution | |
| 400.792E | In distribution | ||
| 447.151 | In distribution | ||
| 447.562 | In distribution | ||
| 401.806 | In distribution | ||
| 487.966 | In distribution | ||
| 446.043 | In distribution | ||
| 401.160 | 5 | In distribution | |
| 400.746E | In distribution | ||
| 447.557 | In distribution | ||
| 487.935 | In distribution | ||
| 401.310 | 5 | In distribution | |
| 446.793 | In distribution | ||
| 401.161E | In distribution | ||
| 487.939 | In distribution | ||
| 400.736E | In distribution | ||
| 487.971 | In distribution | ||
| 400.811 | In distribution | ||
| 487.931 | In distribution | ||
| 202.834 | In distribution | ||
| SD201.930 | In distribution | ||
| 400.788E | In distribution | ||
| 401.814 | In distribution | ||
| 447.155 | In distribution | ||
| 401.307E | In distribution | ||
| 447.152 | In distribution | ||
| 201.826 | In distribution | ||
| 400.806.96 | In distribution | ||
| 401.824 | In distribution | ||
| 401.809.96 | In distribution | ||
| 447.149 | In distribution | ||
| 487.978 | In distribution | ||
| 447.573 | In distribution | ||
| 401.810 | In distribution | ||
| 487.977 | In distribution | ||
| 400.796E | In distribution | ||
| 446.061 | In distribution | ||
| 201.928E | In distribution | ||
| 487.941 | In distribution | ||
| 400.843 | 5 | In distribution | |
| 447.565 | In distribution | ||
| 401.812 | In distribution | ||
| 400.814 | In distribution | ||
| 400.811.96 | In distribution | ||
| 487.967 | In distribution | ||
| 446.045 | In distribution | ||
| 401.314E | In distribution | ||
| 487.976 | In distribution | ||
| 400.796 | 5 | In distribution | |
| 201.812.98 | In distribution | ||
| 401.828 | In distribution | ||
| 487.942 | In distribution | ||
| 400.741 | 5 | In distribution | |
| 201.932E | In distribution | ||
| 446.798 | In distribution | ||
| 446.042 | In distribution | ||
| 487.937 | In distribution | ||
| 447.146 | In distribution | ||
| 201.514 | In distribution | ||
| 401.806.96 | In distribution | ||
| 201.508 | In distribution | ||
| 420.071 | In distribution | ||
| 487.940 | In distribution | ||
| 447.558 | In distribution | ||
| 400.739 | 5 | In distribution | |
| 400.835.20 | 20 | In distribution | |
| 401.168 | 5 | In distribution | |
| 401.159E | In distribution | ||
| 400.834.20 | 20 | In distribution | |
| 395.575 | In distribution | ||
| 447.564 | In distribution | ||
| 292.801 | 10 | In distribution | |
| 201.512 | In distribution | ||
| 201.932 | 5 | In distribution | |
| 400.798E | In distribution | ||
| 447.563 | In distribution | ||
| 487.934 | In distribution | ||
| 446.049 | In distribution | ||
| 201.818 | In distribution | ||
| 487.933 | In distribution | ||
| 400.824 | In distribution | ||
| 401.316 | 5 | In distribution | |
| 446.644 | In distribution | ||
| 400.534 | In distribution | ||
| 400.734 | 5 | In distribution | |
| 400.809 | In distribution | ||
| 401.309 | 5 | In distribution | |
| 446.792 | In distribution | ||
| 401.166E | In distribution | ||
| 446.797 | In distribution | ||
| 446.642 | In distribution | ||
| 400.533 | In distribution | ||
| 400.833 | 5 | In distribution | |
| 400.791E | In distribution | ||
| 400.737E | In distribution | ||
| 400.820.96 | In distribution | ||
| 401.816 | In distribution | ||
| 400.818.96 | In distribution | ||
| 401.834.96 | In distribution | ||
| 400.792 | 5 | In distribution | |
| 400.833E | In distribution | ||
| 400.813.96 | In distribution | ||
| 401.838.96 | In distribution | ||
| 201.836 | In distribution | ||
| 401.308 | 5 | In distribution | |
| 202.808 | In distribution | ||
| 400.786 | 5 | In distribution | |
| 201.810 | In distribution | ||
| 400.843E | 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 |
| 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 |
| CMF | Southern Medical (PTY) Ltd | 37 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
Recalls Naming This Product
7 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 | 2016-02-23 | Class II | Nonconforming Material/Component | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized. | 500 units distributed in USA, and 35 units distributed OUS | 2016-09-08 |
| Synthes (USA) Products LLC | 510(k) number | 2016-02-23 | Class II | Nonconforming Material/Component | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized. | 150 units distributed in US, 1439 units distributed OUS (for | 2016-09-08 |
| Synthes (USA) Products LLC | 510(k) number | 2013-07-30 | Class II | Labeling mix-ups | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. | 13 | 2015-08-17 |
| 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.