FDA 510(k) Application Details - K130625

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K130625
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 Beech Ave.
Unit B6
TORRANCE, CA 90501 US
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Contact ALLYSON PARKS
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 03/08/2013
Decision Date 03/28/2013
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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