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510(k) K832302

MARK I TOTAL KNEE SYS. ARTHROPLASTY by Advanced Biosearch Assn. — Product Code MBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
July 14, 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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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)
  • K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (September 1, 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)