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510(k) K832302

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

K832302 is an FDA 510(k) premarket notification submitted by Advanced Biosearch Assn. for the device "MARK I TOTAL KNEE SYS. ARTHROPLASTY". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Advanced Biosearch Assn. has at least 10 other 510(k) clearances on record.

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

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)
  • 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)

FDA data resources