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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 uncemented acetabular component)
510(k) Number K043547
FOIA Releasable 510(k) K043547
Device Name COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KRO   KWY   KWZ  
LPH   LZO   MEH  
Date Received12/23/2004
Decision Date 08/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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