VOLZ TOTAL WRIST PROSTHESIS
FDA 510(k) clearance K880156 · decided 1988-02-17
Clearance details
- K-number
- K880156
- Device name
- VOLZ TOTAL WRIST PROSTHESIS
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-13
- Decision date
- 1988-02-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KWM
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| M.W.P. WRIST PROSTHESIS (K872502) | Protek, Inc. | 1987-07-23 |
| LAURE WRIST IMPLANT (K803031) | Laure Prosthetics, Inc. | 1982-06-29 |
| TALEISNIK TOTAL WRIST PROSTHESIS (K800602) | Dow Corning Wright | 1980-08-27 |
| WEBER-MAYO WRIST (K801157) | Depuy, Inc. | 1980-08-04 |
| LODA WRIST PROSTHESIS (K790774) | Depuy, Inc. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |