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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K011118
Device Name NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
Applicant
Osteomedics
809 Carter Ln.
Paramus,  NJ  07672
Applicant Contact ALBERT ENAYATI
Correspondent
Osteomedics
809 Carter Ln.
Paramus,  NJ  07672
Correspondent Contact ALBERT ENAYATI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/12/2001
Decision Date 07/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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