Daytona® Small Stature Spinal 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 Daytona® Small Stature Spinal System.

Pre-market Notification Details

Device IDK200381
510k NumberK200381
Device Name:Daytona® Small Stature Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAlicia Mcarthur
CorrespondentAlicia Mcarthur
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-02-28

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