FDA 510(k) Application Details - K121004

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K121004
Device Name Pin, Fixation, Smooth
Applicant APEX TOOLS & ORTHOPEDICS CO.
1331 H STREET NW 12TH FLOOR
WASHINGTON, DC 20005 US
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Contact HOLLACE SAAS RHODES
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 04/03/2012
Decision Date 04/24/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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