CAPSTONE L SPINAL SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDTRONIC SOFAMOR DANEK USA

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

Pre-market Notification Details

Device IDK123978
510k NumberK123978
Device Name:CAPSTONE L SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLauren Kamer
CorrespondentLauren Kamer
MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-26
Decision Date2013-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169133334 K123978 000
00643169132955 K123978 000
00643169133013 K123978 000
00643169133020 K123978 000
00643169133037 K123978 000
00643169133099 K123978 000
00643169133105 K123978 000
00643169133112 K123978 000
00643169133174 K123978 000
00643169133181 K123978 000
00643169133198 K123978 000
00643169132948 K123978 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.