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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 K072020
Device Name RESTORATION ADM SYSTEM
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received07/23/2007
Decision Date 10/18/2007
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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