UNI KNEE


Device Classification Name

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

510(k) Number K022437
Device Name UNI KNEE
Original Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Original Contact joanna droege
Regulation Number 888.3530
Classification Product Code
HRY  
Date Received 07/25/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls