Home / 510(k) Clearances / K830726

510(k) K830726

MARK I & II TOTAL KNEE REPLACE. SYS by Advanced Biosearch Assn. — Product Code MBV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
March 8, 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

Other clearances by Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (December 12, 1988)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855030 — CHAMPY BONE PLATES & BONE SCREWS (January 30, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K853418 — SAFTI-BRACELET (September 20, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)

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)
  • K832302 — MARK I TOTAL KNEE SYS. ARTHROPLASTY (August 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K830408 — FREEMAN/SAMUELSON TOTAL KNEE (February 24, 1983)
  • K822583 — TOTAL KNEE SYSTEM (October 4, 1982)