Universal 2.0 MP AXS
Bone screws, emerg, AXS, self-tapping
3manufacturers in China registered for this device type
51catalogue numbers in this listing
1510(k) clearance
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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-09-15 |
| Record revised | 2026-02-18 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 4 to 20 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 56-20906E | Length 6.0 mm | In distribution | |
| 56-23706 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20704E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20712M | Length 12.0 mm | 25 | In distribution |
| 56-20704M | Length 4.0 mm | 25 | In distribution |
| 56-23708 | Length 8.0 mm | 5 | In distribution |
| 56-20708 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20705M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20718E | Length 18.0 mm | In distribution | |
| 56-20710 | Length 10.0 mm | 5 | In distribution |
| 56-20705E | Length 5.0 mm | In distribution | |
| 56-20905E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20712E | Length 12.0 mm | In distribution | |
| 56-23708E | Length 8.0 mm | In distribution | |
| 56-23716 | Length 16.0 mm | 5 | In distribution |
| 56-20906 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20708M | Length 8.0 mm | 25 | In distribution |
| 56-20712 | Length 12.0 mm | 5 | In distribution |
| 56-20706E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20714 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20720E | Length 20.0 mm | In distribution | |
| 56-20704 | Length 4.0 mm | 5 | In distribution |
| 56-23710 | Length 10.0 mm | 5 | In distribution |
| 56-23712E | Diameter: 2.3 Millimeter | In distribution | |
| 56-23705E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20905M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20710E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23704 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20716 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23706E | Length 6.0 mm | In distribution | |
| 56-23710E | Length 10.0 mm | In distribution | |
| 56-23714E | Length 14.0 mm | In distribution | |
| 56-23704E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20706 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20718 | Length 18.0 mm | 5 | In distribution |
| 56-20714E | Length 14.0 mm | In distribution | |
| 56-20906M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20720 | Length 20.0 mm | 5 | In distribution |
| 56-20905 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20706M | Length 6.0 mm | 25 | In distribution |
| 56-20904 | Length 4.0 mm | 5 | In distribution |
| 56-23714 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20716E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23712 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20705 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20708E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23705 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23716E | Length 16.0 mm | In distribution | |
| 56-20904M | Length 4.0 mm | 25 | In distribution |
| 56-20904E | Length 4.0 mm | In distribution | |
| 56-20710M | Diameter: 2.0 Millimeter | 25 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231599 | 2023-08-24 |
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.