CAPSTONE SPINAL SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Capstone Spinal System.

Pre-market Notification Details

Device IDK121760
510k NumberK121760
Device Name:CAPSTONE SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactBrad Sheals
CorrespondentBrad Sheals
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-15
Decision Date2012-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885074417615 K121760 000

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