Navigated Vertex Select 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 Vertex Select Instruments.

Pre-market Notification Details

Device IDK143628
510k NumberK143628
Device Name:Navigated Vertex Select Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactTejas Patel
CorrespondentTejas Patel
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 Received2014-12-22
Decision Date2015-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169713369 K143628 000
00643169474864 K143628 000
00643169474871 K143628 000
00643169474888 K143628 000
00643169474895 K143628 000
00643169518414 K143628 000
00643169672819 K143628 000
00643169672826 K143628 000
00643169672833 K143628 000
00643169672840 K143628 000
00643169672857 K143628 000
00643169672864 K143628 000
00643169713352 K143628 000
00643169474857 K143628 000

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