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FDA 510(k) Application Details - K193615
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K193615
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad, CA 92008 US
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Contact
Alicia McArthur
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2019
Decision Date
03/25/2020
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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