FDA 510(k) Application Details - K071616

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K071616
Device Name Pin, Fixation, Smooth
Applicant ARC SURGICAL LLC.
21300 NW JACOBSON RD.
HILLSBORO, OR 97124 US
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Contact ED BOEHMER
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 06/13/2007
Decision Date 12/19/2007
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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