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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K201240
Device Name Mariner Cap System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Applicant Contact Alicia McArthur
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Correspondent Contact Alicia McArthur
Regulation Number888.3010
Classification Product Code
OWI  
Date Received05/08/2020
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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