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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 K102080
Device Name DEPUY RECLAIM REVISION HIP SYSTEM
Applicant
DEPUY (IRELAND)
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
DEPUY (IRELAND)
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Correspondent Contact RHONDA MYER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Code
LZO  
Date Received07/26/2010
Decision Date 11/23/2010
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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