GMRS PRESS FIT STEMS WITH PUREFIX HA


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K022403
Device Name GMRS PRESS FIT STEMS WITH PUREFIX HA
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact margaret f crowe
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 07/23/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No