ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN


Device Classification Name

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

510(k) Number K110940
Device Name ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Applicant Contact carol vierling
Correspondent
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Correspodent Contact carol vierling
Regulation Number 888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received 04/04/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No