MatrixMIDFACE
TI Matrixmidface Orbital Floor Plate-Anatomic SMALL/0.3MM TH
3manufacturers in China registered for this device type
65catalogue 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) | K050608 |
| Record published | 2015-09-14 |
| Record revised | 2025-06-09 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.503.343 | In distribution | ||
| 04.503.315 | In distribution | ||
| 04.503.212.05 | 5 | In distribution | |
| 04.503.225.05 | 5 | In distribution | |
| 04.503.345 | In distribution | ||
| 04.503.224.05 | 5 | In distribution | |
| 04.503.392 | In distribution | ||
| 04.503.397 | In distribution | ||
| 04.503.208.20 | 20 | In distribution | |
| 04.503.326 | In distribution | ||
| 04.503.204.05 | 5 | In distribution | |
| 04.503.235.01 | In distribution | ||
| 04.503.242.01 | In distribution | ||
| 04.503.313 | In distribution | ||
| 04.503.205.05 | 5 | In distribution | |
| 04.503.225.20 | 20 | In distribution | |
| 04.503.373 | In distribution | ||
| 04.503.325 | In distribution | ||
| 04.503.234.01 | In distribution | ||
| 04.503.390 | In distribution | ||
| 04.503.375 | In distribution | ||
| 04.503.334 | In distribution | ||
| 04.503.218.05 | 5 | In distribution | |
| 04.503.204.20 | 20 | In distribution | |
| 04.503.233.20 | 20 | In distribution | |
| 04.503.316 | In distribution | ||
| 04.503.226.01 | In distribution | ||
| 04.503.218.01 | In distribution | ||
| 04.503.228.20 | 20 | In distribution | |
| 04.503.203.20 | 20 | In distribution | |
| 04.503.395 | In distribution | ||
| 04.503.362 | In distribution | ||
| 04.503.208.01 | In distribution | ||
| 04.503.318 | In distribution | ||
| 04.503.214.05 | 5 | In distribution | |
| 04.503.246.20 | 20 | In distribution | |
| 04.503.203.01 | In distribution | ||
| 04.503.327 | In distribution | ||
| 04.503.386 | In distribution | ||
| 04.503.384 | In distribution | ||
| 04.503.228.05 | 5 | In distribution | |
| 04.503.203.05 | 5 | In distribution | |
| 04.503.234.05 | 5 | In distribution | |
| 04.503.226.20 | 20 | In distribution | |
| 04.503.238.20 | 20 | In distribution | |
| 04.503.210.05 | 5 | In distribution | |
| 04.503.354 | In distribution | ||
| 04.503.235.05 | 5 | In distribution | |
| 04.503.396 | In distribution | ||
| 04.503.216.20 | 20 | In distribution | |
| 04.503.314 | In distribution | ||
| 04.503.240.05 | 5 | In distribution | |
| 04.503.361 | In distribution | ||
| 04.503.236.05 | 5 | In distribution | |
| 04.503.240.01 | In distribution | ||
| 04.503.206.20 | 20 | In distribution | |
| 04.503.224.20 | 20 | In distribution | |
| 04.503.374 | In distribution | ||
| 04.503.204.01 | In distribution | ||
| 04.503.308 | In distribution | ||
| 04.503.301 | In distribution | ||
| 04.503.363 | In distribution | ||
| 04.503.383 | In distribution | ||
| 04.503.216.05 | 5 | In distribution | |
| 04.503.248.20 | 20 | 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 |
| 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
2 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 GMBH / Synthes Produktions GmbH | 510(k) number | 2020-06-16 | Class II | Under Investigation by firm | One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm). | 41 units | 2022-04-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-06-24 | Class II | Process control | The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation. | 31 | 2016-08-18 |
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.