NEXGEN COMPLETE KNEE SOLUTION – TRABECULAR METAL AUGMENTS


Device Classification Name

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

510(k) Number K024161
Device Name NEXGEN COMPLETE KNEE SOLUTION – TRABECULAR METAL AUGMENTS
Original Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Original Contact marci halevi
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 12/17/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No