Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

Spinal Elements, Inc.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-c Spinal System, Omega Xp Spinal System.

Pre-market Notification Details

Device IDK210044
510k NumberK210044
Device Name:Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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 CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-07
Decision Date2021-06-30

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