Navigated Disc Prep Instruments And CAPSTONE Trials

Orthopedic Stereotaxic Instrument

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 Navigated Disc Prep Instruments And Capstone Trials.

Pre-market Notification Details

Device IDK150231
510k NumberK150231
Device Name:Navigated Disc Prep Instruments And CAPSTONE Trials
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactNicholas Tabrizi
CorrespondentNicholas Tabrizi
MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-06-16
Summary:summary

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