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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 K063002
Device Name ALTRA PRESS-FIT HIP SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46582
Applicant Contact GARY BAKER
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46582
Correspondent Contact GARY BAKER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LPH   LWJ   LZO   MAY   MEH  
Date Received10/02/2006
Decision Date 10/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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