Meridian Anterior Plate System, Regatta Lateral Plate System

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 Meridian Anterior Plate System, Regatta Lateral Plate System.

Pre-market Notification Details

Device IDK200885
510k NumberK200885
Device Name:Meridian Anterior Plate System, Regatta Lateral Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad,  CA  92008
ContactAly Alvarez
CorrespondentAly Alvarez
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 Received2020-04-02
Decision Date2020-05-28

NIH GUDID Devices

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