GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, uncemented

510(k) Number K023692
Device Name GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact margaret f crowe
Regulation Number 888.3360
Classification Product Code
LWJ  
Date Received 11/04/2002
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No