Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

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 Elevate Inserter, Navigated Disc Prep Instruments.

Pre-market Notification Details

Device IDK163581
510k NumberK163581
Device Name:Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLaveeda Leflore
CorrespondentLaveeda Leflore
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 Received2016-12-20
Decision Date2017-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169844070 K163581 000
00763000141400 K163581 000
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00763000141424 K163581 000
00763000124717 K163581 000
00763000124700 K163581 000
00763000124694 K163581 000
00643169747913 K163581 000
00643169747937 K163581 000
00643169747951 K163581 000
00643169764880 K163581 000
00643169771000 K163581 000
00643169771017 K163581 000
00643169771024 K163581 000
00643169835368 K163581 000
00763000124724 K163581 000

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