ARCPM 1050 RESIN-HIPS


Device Classification Name

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

510(k) Number K023357
Device Name ARCPM 1050 RESIN-HIPS
Original Applicant
BIOMET ORTHOPEDICS, INC.
56 eas bell dr.
p.o. box 587
warsaw, 
IN 
46582

Original Contact tracy j bickel
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received 10/07/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No