FDA 510(k) Application Details - K071540

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K071540
Device Name Pin, Fixation, Threaded
Applicant SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK, NY 10022 US
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Contact ROBERT HOEHN
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 06/05/2007
Decision Date 08/08/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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