Mariner RDX System

Thoracolumbosacral Pedicle Screw System

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Rdx System.

Pre-market Notification Details

Device IDK222110
510k NumberK222110
Device Name:Mariner RDX System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactJesse Albright
CorrespondentJesse Albright
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-18
Decision Date2022-09-07

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