CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K030265
Device Name CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Original Contact dalene t binkley
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 01/27/2003
Decision Date 03/04/2003
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