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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K023357
Device Name ARCPM 1050 RESIN-HIPS
Applicant
BIOMET ORTHOPEDICS, INC.
56 EAS BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Applicant Contact TRACY J BICKEL
Correspondent
BIOMET ORTHOPEDICS, INC.
56 EAS BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Correspondent Contact TRACY J BICKEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received10/07/2002
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
Recalls CDRH Recalls
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