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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K091161
Device Name REJUVENATE MONOLITHIC SIZE 4 HIP STEM
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact ESTELA CELI
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact ESTELA CELI
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
JDI   KWY   KWZ   LPH   LWJ  
LZO  
Date Received04/21/2009
Decision Date 06/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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