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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K191648
Device Name Mariner MIS Pedicle Screw System; SeaSpine Navigation System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
carlsbad,  CA  92008
Applicant Contact alicia mcarthur
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
carlsbad,  CA  92008
Correspondent Contact aly alvarez
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   OLO  
Date Received06/20/2019
Decision Date 07/19/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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