NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS


Device Classification Name

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

510(k) Number K023211
Device Name NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Original Contact stephen h mckelvey
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 09/26/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls