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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 K222110
Device Name Mariner RDX System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Applicant Contact Jesse Albright
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Correspondent Contact Jesse Albright
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received07/18/2022
Decision Date 09/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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