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FDA 510(k) Application Details - K212139
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K212139
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad, CA 92008 US
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Contact
Cindy Fong
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2021
Decision Date
09/01/2021
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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