Mariner Deformity 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 Deformity System.

Pre-market Notification Details

Device IDK211606
510k NumberK211606
Device Name:Mariner Deformity 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-25
Decision Date2021-06-23

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