Universal Mandible AXS
Locking screws, emerg, AXS, self-tapping
3manufacturers in China registered for this device type
148catalogue 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 | 2023-09-14 |
| 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 |
|---|---|---|---|
| 56-20497E | Diameter: 2.0 Millimeter | In distribution | |
| 56-27405E | Diameter: 2.7 Millimeter | In distribution | |
| 56-20410E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23510E | Diameter: 2.3 Millimeter | In distribution | |
| 56-23520E | Length 20.0 mm | In distribution | |
| 56-23410E | Length 10.0 mm | In distribution | |
| 56-23506 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20406E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23414 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23520 | Length 20.0 mm | 5 | In distribution |
| 56-20412 | Length 12.0 mm | 5 | In distribution |
| 56-20506M | Length 6.0 mm | 25 | In distribution |
| 56-23416E | Length 16.0 mm | In distribution | |
| 56-20512E | Length 12.0 mm | In distribution | |
| 56-20506 | Length 6.0 mm | 5 | In distribution |
| 56-20404 | Length 4.0 mm | 5 | In distribution |
| 56-27414 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 56-20406 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20494M | Length 4.0 mm | 25 | In distribution |
| 56-23514 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23514E | Length 14.0 mm | In distribution | |
| 56-23508E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20407 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20416 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23506E | Length 6.0 mm | In distribution | |
| 56-27508 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 56-27508E | Diameter: 2.7 Millimeter | In distribution | |
| 56-20494E | Length 4.0 mm | In distribution | |
| 56-27505 | Length 5.0 mm | 5 | In distribution |
| 56-20406M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20594E | Length 4.0 mm | In distribution | |
| 56-20510M | Length 10.0 mm | 25 | In distribution |
| 56-20505M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-23518E | Diameter: 2.3 Millimeter | In distribution | |
| 56-23420E | Length 20.0 mm | In distribution | |
| 56-27510 | Length 10.0 mm | 5 | In distribution |
| 56-20414E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23512E | Length 12.0 mm | In distribution | |
| 56-27514 | Length 14.0 mm | 5 | In distribution |
| 56-20508E | Diameter: 2.0 Millimeter | In distribution | |
| 56-27512 | Length 12.0 mm | 5 | In distribution |
| 56-20405 | Length 5.0 mm | 5 | In distribution |
| 56-20504E | Length 4.0 mm | In distribution | |
| 56-27518 | Length 18.0 mm | 5 | In distribution |
| 56-20416E | Length 16.0 mm | In distribution | |
| 56-27420 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 56-27516 | Length 16.0 mm | 5 | In distribution |
| 56-20507 | Length 7.0 mm | 5 | In distribution |
| 56-23408E | Length 8.0 mm | In distribution | |
| 56-20510E | Length 10.0 mm | In distribution | |
| 56-23408 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20595E | Length 5.0 mm | In distribution | |
| 56-20412E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20414 | Length 14.0 mm | 5 | In distribution |
| 56-27512E | Length 12.0 mm | In distribution | |
| 56-27412E | Length 12.0 mm | In distribution | |
| 56-20510 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-27410E | Diameter: 2.7 Millimeter | In distribution | |
| 56-27510E | Length 10.0 mm | In distribution | |
| 56-20496E | Length 6.0 mm | In distribution | |
| 56-27520 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 56-20418E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23516E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20410 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20514 | Length 14.0 mm | 5 | In distribution |
| 56-23504E | Length 4.0 mm | In distribution | |
| 56-23412E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20495E | Diameter: 2.0 Millimeter | In distribution | |
| 56-23508 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20408M | Length 8.0 mm | 25 | In distribution |
| 56-23420 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23510 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20495M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20596E | Length 6.0 mm | In distribution | |
| 56-20520E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20514E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20596 | Length 6.0 mm | 5 | In distribution |
| 56-20497 | Length 7.0 mm | 5 | In distribution |
| 56-20410M | Length 10.0 mm | 25 | In distribution |
| 56-23412 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23518 | Length 18.0 mm | 5 | In distribution |
| 56-27514E | Length 14.0 mm | In distribution | |
| 56-20504M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20496M | Length 6.0 mm | 25 | In distribution |
| 56-20412M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20408E | Length 8.0 mm | In distribution | |
| 56-27410 | Length 10.0 mm | 5 | In distribution |
| 56-20520 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-27414E | Length 14.0 mm | In distribution | |
| 56-23418 | Length 18.0 mm | 5 | In distribution |
| 56-20508 | Length 8.0 mm | 5 | In distribution |
| 56-20404E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20516 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20597 | Length 7.0 mm | 5 | In distribution |
| 56-27416 | Length 16.0 mm | 5 | In distribution |
| 56-27418E | Length 18.0 mm | In distribution | |
| 56-20507E | Diameter: 2.0 Millimeter | In distribution | |
| 56-27405 | Length 5.0 mm | 5 | In distribution |
| 56-20420 | Length 20.0 mm | 5 | In distribution |
| 56-20597M | Length 7.0 mm | 25 | In distribution |
| 56-27420E | Length 20.0 mm | In distribution | |
| 56-20505E | Length 5.0 mm | In distribution | |
| 56-20518 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20594M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20496 | Length 6.0 mm | 5 | In distribution |
| 56-20504 | Length 4.0 mm | 5 | In distribution |
| 56-23406E | Diameter: 2.3 Millimeter | In distribution | |
| 56-20494 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20508M | Length 8.0 mm | 25 | In distribution |
| 56-27416E | Length 16.0 mm | In distribution | |
| 56-27408 | Length 8.0 mm | 5 | In distribution |
| 56-27518E | Diameter: 2.7 Millimeter | In distribution | |
| 56-20596M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-27412 | Length 12.0 mm | 5 | In distribution |
| 56-20506E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20418 | Length 18.0 mm | 5 | In distribution |
| 56-20594 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23404E | Diameter: 2.3 Millimeter | In distribution | |
| 56-27505E | Length 5.0 mm | In distribution | |
| 56-20505 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23418E | Diameter: 2.3 Millimeter | In distribution | |
| 56-23406 | Length 6.0 mm | 5 | In distribution |
| 56-23416 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20595M | Length 5.0 mm | 25 | In distribution |
| 56-27418 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 56-20495 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-20595 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23404 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-23414E | Length 14.0 mm | In distribution | |
| 56-20408 | Length 8.0 mm | 5 | In distribution |
| 56-27520E | Length 20.0 mm | In distribution | |
| 56-20497M | Length 7.0 mm | 25 | In distribution |
| 56-20597E | Length 7.0 mm | In distribution | |
| 56-20512 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 56-23410 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20512M | Diameter: 2.0 Millimeter | 25 | In distribution |
| 56-20420E | Length 20.0 mm | In distribution | |
| 56-20405M | Length 5.0 mm | 25 | In distribution |
| 56-23504 | Length 4.0 mm | 5 | In distribution |
| 56-23516 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20404M | Length 4.0 mm | 25 | In distribution |
| 56-27408E | Length 8.0 mm | In distribution | |
| 56-20407E | Length 7.0 mm | In distribution | |
| 56-23512 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 56-20518E | Diameter: 2.0 Millimeter | In distribution | |
| 56-20516E | Diameter: 2.0 Millimeter | In distribution | |
| 56-27516E | Length 16.0 mm | In distribution | |
| 56-20405E | Diameter: 2.0 Millimeter | 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 |
| 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 |
| 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.