GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)


Device Classification Name

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

510(k) Number K023087
Device Name GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact margaret f crowe
Regulation Number 888.3510
Classification Product Code
KRO  
Subsequent Product Code
JDI  
Date Received 09/17/2002
Decision Date 12/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls