FDA 510(k) Application Details - K143214

Device Classification Name

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510(K) Number K143214
Device Name SCARLET« AC-T Secured Anterior Cervical Cage
Applicant SPINEART
lnternational Center Cointrin 20 route de prΘ-bois CP1813
GENEVA 1215 CH
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Contact Franck PENNESI
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Regulation Number

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Classification Product Code OVE
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Date Received 11/10/2014
Decision Date 02/23/2015
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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