FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
FDA 510(k) clearance K931265 · decided 1995-05-22
Clearance details
- K-number
- K931265
- Device name
- FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
- Applicant
- Ferguson Medical
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-03-08
- Decision date
- 1995-05-22
- Days to decision
- 805 days
- Clearance type
- Traditional
- Product code
- JWI
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Chico, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIVERSAL WRIST (K940297) | Turnkey Intergration USA, Inc. | 1995-02-06 |
| ASPERGILLUS SP., ANTIGEN (K792687) | Meridian Diagnostics, Inc. | 1980-01-17 |
Recalls involving this device
No recalls on record reference this clearance.