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Medtronic Sofamor Danek USA, Inc.

FDA 510(k) & PMA Approved Devices — 79 products

Total Devices79
Categories19
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
510(k) K173338 Navigated INFINITY™ InstrumentsOLO2018-01-18 View
510(k) K172328 SOVEREIGN™ Spinal SystemOVD2017-11-02 View
510(k) K171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC TechnologyMAX2017-10-05 View
510(k) K171107 CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMAX2017-09-26 View
510(k) K163375 INFINITY™ OCT SystemNKG2017-08-21 View
510(k) K162212 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEMMAX2017-05-19 View
510(k) K163181 TRANSLACE™ Spinal Tethering SystemOWI2017-05-16 View
510(k) K163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsOLO2017-04-14 View
510(k) K163279 Medtronic Transportation/Sterilization CassettesKCT2017-02-23 View
510(k) K163301 CD HORIZON® Spinal SystemNKB2016-12-20 View
510(k) K162680 SOVEREIGN® Spinal SystemOVD2016-12-14 View
510(k) K162379 CD HORIZON® Spinal SystemNKB2016-11-16 View
510(k) K162494 CD HORIZON® Spinal SystemNKB2016-10-04 View
510(k) K160528 ANATOMIC PEEK PTC Cervical Fusion SystemODP2016-03-28 View
510(k) K160418 PERIMETER Interbody Fusion DeviceMAX2016-03-07 View
510(k) K153438 PERIMETER C (Titanium) Spinal SystemODP2016-03-02 View
510(k) K153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE SystemsNKB2016-02-18 View
510(k) K153589 CD HORIZON Spinal SystemNKB2016-02-10 View
510(k) K152241 Medtronic Transportation/Sterilization CassettesKCT2016-01-20 View

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