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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K163581

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments · Medtronic Sofamor Danek USA, Inc. · decided 2017-04-14 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)NAV2137MEDTRONIC SOFAMOR DANEK, INC.OLO00643169747913
ELEVATE™ Spinal SystemNAV2134MEDTRONIC SOFAMOR DANEK, INC.OLO00763000141424
(unnamed)NAV2142MEDTRONIC SOFAMOR DANEK, INC.OLO00643169835368
ELEVATE™ Spinal SystemNAV2043MEDTRONIC SOFAMOR DANEK, INC.OLO00643169764880
ELEVATE™ Spinal SystemNAV2132MEDTRONIC SOFAMOR DANEK, INC.OLO00763000880385
ELEVATE™ Spinal SystemNAV2134MEDTRONIC SOFAMOR DANEK, INC.OLO00763000880408
ELEVATE™ Spinal SystemNAV2141MEDTRONIC SOFAMOR DANEK, INC.OLO00763000124717
(unnamed)NAV2137MEDTRONIC SOFAMOR DANEK, INC.OLO00763000124694
(unnamed)NAV2142MEDTRONIC SOFAMOR DANEK, INC.OLO00763000124724
ELEVATE™ Spinal SystemNAV2143MEDTRONIC SOFAMOR DANEK, INC.OLO00643169844070
ELEVATE™ Spinal SystemNAV2133MEDTRONIC SOFAMOR DANEK, INC.OLO00763000880392
ELEVATE™ Spinal SystemNAV2133MEDTRONIC SOFAMOR DANEK, INC.OLO00763000141417
(unnamed)NAV2139MEDTRONIC SOFAMOR DANEK, INC.OLO00643169747937
ELEVATE™ Spinal SystemNAV2134MEDTRONIC SOFAMOR DANEK, INC.OLO00643169771017
(unnamed)NAV2137MEDTRONIC SOFAMOR DANEK, INC.OLO00763000013356
ELEVATE™ Spinal SystemNAV2133MEDTRONIC SOFAMOR DANEK, INC.OLO00643169771024
ELEVATE™ Spinal SystemNAV2132MEDTRONIC SOFAMOR DANEK, INC.OLO00763000141400
(unnamed)NAV2139MEDTRONIC SOFAMOR DANEK, INC.OLO00763000124700
ELEVATE™ Spinal SystemNAV2132MEDTRONIC SOFAMOR DANEK, INC.OLO00643169771000
(unnamed)NAV2141MEDTRONIC SOFAMOR DANEK, INC.OLO00643169747951