510(k) K800602
- Device
- TALEISNIK TOTAL WRIST PROSTHESIS
- Applicant
- DOW CORNING WRIGHT
- 510(k) number
- K800602
- Product code
- KWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-27
- Date received
- 1980-03-17
- 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 |
| K801157 | WEBER-MAYO WRIST | Depuy, Inc. | 1980-08-04 |
| K790774 | LODA WRIST PROSTHESIS | Depuy, Inc. | 1979-08-03 |
Legacy Summary#
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FDA Review#
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