VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES


Device Classification Name

prosthesis, hip, semi-constrained (metal cemented acetabular component)

510(k) Number K073499
Device Name VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Applicant Contact eric s pittman
Correspondent
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Correspodent Contact eric s pittman
Regulation Number 888.3320
Classification Product Code
JDL  
Subsequent Product Code
LPH  
Date Received 12/13/2007
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No