Home / 510(k) Clearances / K800602

510(k) K800602

TALEISNIK TOTAL WRIST PROSTHESIS by Dow Corning Wright — Product Code KWM

K800602 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "TALEISNIK TOTAL WRIST PROSTHESIS". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code KWM (Prosthesis, Wrist, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

Other clearances by Dow Corning Wright

  • K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (September 7, 1994)
  • K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (June 30, 1994)
  • K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT (June 3, 1994)
  • K932222 — SLT FEMORAL HEAD (May 27, 1994)
  • K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (February 16, 1994)
  • K930228 — ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (November 30, 1993)
  • K925900 — LACEY REVISION FEMORAL COMPONENT (August 24, 1993)
  • K930189 — ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (August 6, 1993)
  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

Other clearances for product code KWM

  • K880156 — VOLZ TOTAL WRIST PROSTHESIS (February 17, 1988)
  • K872502 — M.W.P. WRIST PROSTHESIS (July 23, 1987)
  • K803031 — LAURE WRIST IMPLANT (June 29, 1982)
  • K801157 — WEBER-MAYO WRIST (August 4, 1980)
  • K790774 — LODA WRIST PROSTHESIS (August 3, 1979)

FDA data resources