FDA 510(k) Application Details - K142213

Device Classification Name

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510(K) Number K142213
Device Name VIA SPINOUS PROCESS FIXATION SYSTEM
Applicant SPINEOLOGY, INC.
7800 3RD STREET NORTH
SAINT PAUL, MN 55128 US
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Contact TIM CRABTREE
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Regulation Number

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Classification Product Code PEK
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Date Received 08/12/2014
Decision Date 09/10/2014
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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