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510(k) K831441

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE by Depuy, Inc. — Product Code MBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
May 5, 1983
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

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  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
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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)
  • K853730 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP (February 18, 1986)
  • K833200 — TRICON M TOTAL KNEE SYSTEM (November 29, 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)