510(k) K801157
- Device
- Weber-mayo Wrist
- Applicant
- DEPUY, INC.
- 510(k) number
- K801157
- Product code
- KWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-04
- Date received
- 1980-05-14
- Regulation
- 888.3800
- Classification name
- Prosthesis, Wrist, Semi-Constrained
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007289093
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880156 | VOLZ TOTAL WRIST PROSTHESIS | Biomet, Inc. | 1988-02-17 |
| K872502 | M.W.P. WRIST PROSTHESIS | Protek, Inc. | 1987-07-23 |
| K803031 | LAURE WRIST IMPLANT | Laure Prosthetics, Inc. | 1982-06-29 |
| K800602 | TALEISNIK TOTAL WRIST PROSTHESIS | Dow Corning Wright | 1980-08-27 |
| K790774 | LODA WRIST PROSTHESIS | Depuy, Inc. | 1979-08-03 |