ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32


Device Classification Name

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

510(k) Number K030153
Device Name ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Original Contact karen cain
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 01/16/2003
Decision Date 04/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No