ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Elevate Spinal System, Capstone Ptc Spinal System, Crescent Spinal System, Crescent Spinal System Titanium.

Pre-market Notification Details

Device IDK172199
510k NumberK172199
Device Name:ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
ContactJustin O'connor
CorrespondentJustin O'connor
Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-21
Decision Date2017-09-19
Summary:summary

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