AXS
Screw, AXS, Self-Drilling
3manufacturers in China registered for this device type
14catalogue 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 |
| Quanzhou Apex Hygiene Products Co., Ltd. | Jinjiang | Fujian | Manufacturer | 8 |
Record
| Listed by | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K171152 |
| Record published | 2017-05-30 |
| Record revised | 2024-06-19 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 3 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 56-15933S1 | Length 3.0 mm | In distribution | |
| 56-15933S4 | Length 3.0 mm | 4 | In distribution |
| 56-15935S1 | Diameter: 1.5 Millimeter | In distribution | |
| 56-15036S1 | Diameter: 1.5 Millimeter | In distribution | |
| 56-15034S4 | Diameter: 1.5 Millimeter | 4 | In distribution |
| 56-15034S1 | Length 4.0 mm | In distribution | |
| 56-17334S4 | Length 4.0 mm | 4 | In distribution |
| 56-15934S1 | Length 4.0 mm | In distribution | |
| 56-15036S4 | Length 6.0 mm | 4 | In distribution |
| 56-15934S4 | Length 4.0 mm | 4 | In distribution |
| 56-15035S4 | Diameter: 1.5 Millimeter | 4 | In distribution |
| 56-15935S4 | Diameter: 1.5 Millimeter | 4 | In distribution |
| 56-17334S1 | Diameter: 1.7 Millimeter | In distribution | |
| 56-15035S1 | Length 5.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 87 |
| Neuro Plating System | Osteonic Co., Ltd. | 55 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 40 |
| “2.0MM” System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 18 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 15 |
| CMF System | Biomet Microfixation | 14 |
| Fastener, Plate, Cranioplasty | Biomet Microfixation | 14 |
| Raas Cranial Plating System | Alliance Partners, LLC | 12 |
| Thinflap System | Biomet Microfixation | 12 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 11 |
| NeuroPro® Low Profile | Kinamed, Inc. | 10 |
Showing 12 of 45. All products under Fastener, Plate, Cranioplasty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231208 | 2023-08-14 |
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.