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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K051411
FOIA Releasable 510(k) K051411
Device Name ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46582
Correspondent Contact TRACY BICKEL JOHNSON
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/31/2005
Decision Date 06/29/2005
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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