FDA 510(k) Application Details - K150053

Device Classification Name

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510(K) Number K150053
Device Name STALIF C; STALIF C-Ti
Applicant Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380 US
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Contact John Parry
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Regulation Number

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Classification Product Code OVE
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Date Received 01/12/2015
Decision Date 06/24/2015
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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