FDA 510(k) Application Details - K131880

Device Classification Name

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510(K) Number K131880
Device Name SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
Applicant SPINEFRONTIER, INC.
4628 NORTHPARK DRIVE
COLORADO SPRINGS, CO 80918 US
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Contact MEREDITH MAY
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Regulation Number

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Classification Product Code OVE
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Date Received 06/25/2013
Decision Date 01/03/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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