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510(k) K872502

M.W.P. WRIST PROSTHESIS by Protek, Inc. — Product Code KWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1987
Date Received
June 24, 1987
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 Protek, Inc.

  • K893785 — ARC-2F ACETABULAR CUP (August 9, 1989)
  • K893959 — P.S.A. FEMORAL HIP PROSTHESIS (July 25, 1989)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)
  • K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH (May 26, 1989)
  • K884952 — VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC (May 10, 1989)
  • K884889 — MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (February 27, 1989)
  • K890054 — M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. (February 8, 1989)
  • K884789 — NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI (February 8, 1989)
  • K884888 — MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS (December 29, 1988)
  • K882671 — SAMUELSON SCREWLOC CUP (October 20, 1988)

Other clearances for product code KWM

  • K880156 — VOLZ TOTAL WRIST PROSTHESIS (February 17, 1988)
  • K803031 — LAURE WRIST IMPLANT (June 29, 1982)
  • K800602 — TALEISNIK TOTAL WRIST PROSTHESIS (August 27, 1980)
  • K801157 — WEBER-MAYO WRIST (August 4, 1980)
  • K790774 — LODA WRIST PROSTHESIS (August 3, 1979)