BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K073567
Device Name BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
Applicant
ZIMMER GMBH
p.o. box 708
warsaw, 
IN 
46581 -0708

Applicant Contact patricia jenks
Correspondent
ZIMMER GMBH
p.o. box 708
warsaw, 
IN 
46581 -0708

Correspodent Contact patricia jenks
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 12/20/2007
Decision Date 03/13/2008
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