Taleisnik Total Wrist Prosthesis
FDA 510(k) K800602 · Dow Corning Wright
510(k) numberK800602
Submission
- Device name
- Taleisnik Total Wrist Prosthesis
- Applicant
- Dow Corning Wright
Mchenry, IL, US - Received
- March 17, 1980
- Decision date
- August 27, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWM – Prosthesis, Wrist, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880156 | Volz Total Wrist ProsthesisKWM · Traditional | Biomet, Inc. | 02/17/1988SE |
| K872502 | M.W.P. Wrist ProsthesisKWM · Traditional | Protek, Inc. | 07/23/1987SE |
| K803031 | Laure Wrist ImplantKWM · Traditional | Laure Prosthetics, Inc. | 06/29/1982SE |
| K801157 | Weber-Mayo WristKWM · Traditional | Depuy, Inc. | 08/04/1980SE |
| K790774 | Loda Wrist ProsthesisKWM · Traditional | Depuy, Inc. | 08/03/1979SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932210 | Ortholoc Advantim Revision Femoral ComponentJWH · Traditional | 09/07/1994SN |
| K932911 | Ortholoc Advantim L.S. Tibial ComponentJWH · Traditional | 06/30/1994SN |
| K934354 | Lacey All Polyethylene Tibial ComponentJWH · Traditional | 06/03/1994SE |
| K932222 | SLT Femoral HeadLZO · Traditional | 05/27/1994SE |
| K932858 | Ortholoc Advantim Tibial Base ComponentJWH · Traditional | 02/16/1994SE |
| K930228 | Ortholoc Advantim Tibial Stem 5 DegreeJWH · Traditional | 11/30/1993SE |
| K925900 | Lacey Revision Femoral ComponentJWH · Traditional | 08/24/1993SE |
| K930189 | Ortholoc(R) Advantim(Tm) Posterior Stab Femor CompJWH · Traditional | 08/06/1993SN |
| K930188 | Ortholoc(R) Advantim(Tm) Femoral ComponentJWH · Traditional | 08/03/1993SE |
| K930190 | Ortholoc(R) Advantim(Tm) Non-Por Coat Femor CompJWH · Traditional | 08/02/1993SE |
Questions and answers
When was Taleisnik Total Wrist Prosthesis cleared by the FDA?
Taleisnik Total Wrist Prosthesis (K800602) received a 510(k) decision of Substantially Equivalent on August 27, 1980, 163 days after the submission was received.
What is the product code of K800602?
The FDA product code is KWM – Prosthesis, Wrist, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.