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FDA 510(k) Application Details - K190655
Device Classification Name
More FDA Info for this Device
510(K) Number
K190655
Device Name
SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad, CA 92008 US
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Contact
Alicia McArthur
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Regulation Number
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Classification Product Code
OVE
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Date Received
03/14/2019
Decision Date
04/29/2019
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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