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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K071656
Device Name SBI ARTFIX
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 Number888.3040
Classification Product Code
HWC  
Date Received05/29/2007
Decision Date 08/27/2007
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
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