FuzeFix Chamfered Screws
Manual Rasp Mirror
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
Record
| Listed by | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | QBO |
| Device type | Instruments Designed For Press-Fit Osteochondral Implants |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4505 |
| 510(k) | K170038 |
| Record published | 2025-05-16 |
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, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TN-CS-8500 | In distribution | |
| TN-CS-8500 | In distribution | |
| TN-CS-8060 | In distribution | |
| TN-CS-8055 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Actis | Depuy (Ireland) | 13 |
| Emphasys | Depuy (Ireland) | 13 |
| C-Stem | Depuy (Ireland) | 12 |
| PolyPrep | Fusion Orthopedics, LLC | 6 |
| Cartiva SCI Metatarsal Drill Bit | Cartiva, Inc. | 4 |
| Cartiva Disposable Instrument Set | Cartiva, Inc. | 4 |
| Cartiva SCI Introducer | Cartiva, Inc. | 4 |
| Cartiva SCI Placer | Cartiva, Inc. | 4 |
| Instrumentation Set – for Use with Osteochondral Allograft, PRE-CUT Core | Swami Medical | 3 |
| Agili-C Toolset | Cartiheal (2009) Ltd | 3 |
| Cartiheal Agili-C Disposable Toolset 10 | T.A.G Medical Products Agricultural Cooperative Association | 2 |
| Cartiva MTP Sizer | Cartiva, Inc. | 1 |
Showing 12 of 19. All products under Instruments Designed For Press-Fit Osteochondral Implants
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.