HLS UNI EVOLUTION PROSTHESIS


Device Classification Name

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

510(k) Number K022211
Device Name HLS UNI EVOLUTION PROSTHESIS
Original Applicant
TORNIER
zirst-161, rue lavoisier
montbonnot, 

FR

38330

Original Contact mireille lemery
Regulation Number 888.3520
Classification Product Code
HSX  
Date Received 07/08/2002
Decision Date 05/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No