Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Appliance, Fixation, Spinal Intervertebral Body

Spinal Elements, Inc.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System.

Pre-market Notification Details

Device IDK201029
510k NumberK201029
Device Name:Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Spinal Elements, Inc. 3115 Melrose Dr. Suite 200 Carlsbad,  CA  92010
ContactJulie Lamothe
CorrespondentJulie Lamothe
Spinal Elements, Inc. 3115 Melrose Dr. Suite 200 Carlsbad,  CA  92010
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2020-06-17

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