ANTERIOR STABILIZED TIBIAL BEARINGS


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K022586
Device Name ANTERIOR STABILIZED TIBIAL BEARINGS
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact dalene t binkley
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 08/05/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No