Navigated Anterolateral 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 Anterolateral Disc Prep Instruments.

Pre-market Notification Details

Device IDK192336
510k NumberK192336
Device Name:Navigated Anterolateral Disc Prep Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
ContactParwinder Singh
CorrespondentParwinder Singh
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 Received2019-08-28
Decision Date2019-11-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000252021 K192336 000
00763000200787 K192336 000
00763000200794 K192336 000
00763000200800 K192336 000
00763000200817 K192336 000
00763000200824 K192336 000
00763000200831 K192336 000
00763000200848 K192336 000
00763000200862 K192336 000
00763000200879 K192336 000
00763000200886 K192336 000
00763000200893 K192336 000
00763000200909 K192336 000
00763000200916 K192336 000
00763000200923 K192336 000
00763000200930 K192336 000
00763000209728 K192336 000
00763000226275 K192336 000
00763000200855 K192336 000

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