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510(k) K853730

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP by Protek, Inc. — Product Code MBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1986
Date Received
September 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
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 MBV

  • K010212 — OFFSET TIBIAL TRAY (February 14, 2001)
  • K884824 — TRICON-M TOTAL KNEE SYSTEM (November 21, 1989)
  • K873429 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE (October 28, 1987)
  • K833200 — TRICON M TOTAL KNEE SYSTEM (November 29, 1983)
  • K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (September 1, 1983)
  • K832302 — MARK I TOTAL KNEE SYS. ARTHROPLASTY (August 16, 1983)
  • K830726 — MARK I & II TOTAL KNEE REPLACE. SYS (June 22, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K830408 — FREEMAN/SAMUELSON TOTAL KNEE (February 24, 1983)
  • K822583 — TOTAL KNEE SYSTEM (October 4, 1982)