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FDA 510(k) Application Details - K201646
Device Classification Name
More FDA Info for this Device
510(K) Number
K201646
Device Name
Shoreline ACS (Anterior Cervical 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
06/17/2020
Decision Date
09/14/2020
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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