WEBER-MAYO WRIST
FDA 510(k) clearance K801157 · decided 1980-08-04
Clearance details
- K-number
- K801157
- Device name
- WEBER-MAYO WRIST
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-14
- Decision date
- 1980-08-04
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- KWM
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| VOLZ TOTAL WRIST PROSTHESIS (K880156) | Biomet, Inc. | 1988-02-17 |
| 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 |
| 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 |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |