FDA 510(k) Application Details - K143228

Device Classification Name

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510(K) Number K143228
Device Name Ancora LLC Interbody Fusion Device
Applicant FRONTIER MEDICAL DEVICES, INC.
512 FOURTH STREET
GWINN, MI 49841 US
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Contact ERIC SEABORG
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Regulation Number

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Classification Product Code OVD
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Date Received 11/10/2014
Decision Date 02/26/2015
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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