PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING


Device Classification Name

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

510(k) Number K022094
Device Name PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
Original Applicant
BIOMET, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact tracy j bickel
Regulation Number 888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received 06/27/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No