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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K071394
Device Name MODIFICATION TO:SBI RINGFIX
Applicant
Small Bone Innovations, Inc.
505 Park Ave., 14th Floor
New York,  NY  10022
Applicant Contact ROBERT HOEHN
Correspondent
Small Bone Innovations, Inc.
505 Park Ave., 14th Floor
New York,  NY  10022
Correspondent Contact ROBERT HOEHN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/21/2007
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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