510(k) K880156
- Device
- Volz Total Wrist Prosthesis
- Applicant
- BIOMET, INC.
- 510(k) number
- K880156
- Product code
- KWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-17
- Date received
- 1988-01-13
- 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#
- Contact
- PATRICIA M SANDBORN
- Address
- P.O. Box 587 Warsaw IN US 46581 46581
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 |
|---|---|---|---|
| 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 |
| K801157 | WEBER-MAYO WRIST | Depuy, Inc. | 1980-08-04 |
| K790774 | LODA WRIST PROSTHESIS | Depuy, Inc. | 1979-08-03 |