Shoreline Threaded TruProfile® Plate

Appliance, Fixation, Spinal Intervertebral Body

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Shoreline Threaded Truprofile® Plate.

Pre-market Notification Details

Device IDK211903
510k NumberK211903
Device Name:Shoreline Threaded TruProfile® Plate
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactKavita Chandrashekar
CorrespondentKavita Chandrashekar
SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-08-30
Summary:summary

NIH GUDID Devices

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