MARK I & II TOTAL KNEE REPLACE. SYS— 510(k) K830726

Name: FDA 510(k) clearance K830726
Creator: U.S. Food and Drug Administration
Published: 1983-06-22

Substantially Equivalent

Advanced Biosearch Assn.

FDA 510(k) clearance K830726 for MARK I & II TOTAL KNEE REPLACE. SYS, Substantially Equivalent on 1983-06-22. Applicant: Advanced Biosearch Assn.. Device class: 2.

Clearance details

Applicant: Advanced Biosearch Assn.
Product code: Code MBV
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1983-03-08
Decision date: 1983-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBV

view all

K010212 — OFFSET TIBIAL TRAY2001-02-14
K884824 — TRICON-M TOTAL KNEE SYSTEM1989-11-21
K873429 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE1987-10-28
K853730 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP1986-02-18
K833200 — TRICON M TOTAL KNEE SYSTEM1983-11-29

More clearances from Advanced Biosearch Assn.

view all

K905514 — AUTOGENESIS(TM) AUTOMATOR1991-04-02
K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.1988-12-12
K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM1986-02-11
K855030 — CHAMPY BONE PLATES & BONE SCREWS1986-01-30
K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P1986-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.