LAURE WRIST IMPLANT
FDA 510(k) clearance K803031 · decided 1982-06-29
Clearance details
- K-number
- K803031
- Device name
- LAURE WRIST IMPLANT
- Applicant
- Laure Prosthetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-28
- Decision date
- 1982-06-29
- Days to decision
- 578 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 |
| 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.