MODIFICATION TO AVALON CUP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K022711
Device Name MODIFICATION TO AVALON CUP SYSTEM
Original Applicant
ORTHOPEDIC SOURCE INC.
5975 horseshoe bar rd.
p.o. box 307
loomis, 
CA 
95650

Original Contact steven m mandell
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 08/14/2002
Decision Date 08/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No