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FDA 510(k) Application Details - K231654
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K231654
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
SeaSpine Inc.
5770 Armada Dr.
Carlsbad, CA 92008 US
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Contact
Jesse Albright
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
06/06/2023
Decision Date
08/03/2023
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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