NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS


Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K072619
Device Name NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Applicant Contact daniel j williman
Correspondent
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Correspodent Contact daniel j williman
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received 09/17/2007
Decision Date 11/21/2007
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