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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 K062998
FOIA Releasable 510(k) K062998
Device Name COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact JING XIE
Correspondent
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact JING XIE
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KRO   KWY   KWZ  
LPH   LZO   MEH  
Date Received10/02/2006
Decision Date 01/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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