The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Fixano Total Trapezio Metacarpal Prosthesis, 2nd.
| Device ID | K931265 |
| 510k Number | K931265 |
| Device Name: | FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND |
| Classification | Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | JWI |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1995-05-22 |