Medtronic Sofamor Danek USA, I

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek USA, I. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Medtronic Sofamor Danek USA, INC.
Navigated Anterolateral Disc Prep Instruments2019-11-22
Medtronic Sofamor Danek USA, INC.
Medtronic Transportation / Sterilization Cassettes2019-10-15
Medtronic Sofamor Danek USA, Inc
ARTiC-L 3D Ti Spinal System With TiONIC Technology, ARTiC-XL 3D Ti Spinal System With TiONIC Technology2019-07-03
Medtronic Sofamor Danek USA, INC.
Capstone Control™ Spinal System2019-05-06
Medtronic Sofamor Danek USA, INC.
PYRAMESH™ Implant System2019-04-04
Medtronic Sofamor Danek USA, Inc.
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System And Zevo™ Anterior Cervical Plate System2019-02-06
Medtronic Sofamor Danek USA, Inc.
POWEREASE System2018-10-04
Medtronic Sofamor Danek USA, Inc.
CD HORIZON™ Spinal System2018-08-29
Medtronic Sofamor Danek USA, Inc.
KYPHON HV-R Bone Cement2018-05-18
Medtronic Sofamor Danek USA, Inc.
Navigated INFINITY Instruments2018-05-17
Medtronic Sofamor Danek USA, Inc
VERTEX™ Reconstruction System2018-04-18
Medtronic Sofamor Danek USA, Inc.
CD HORIZON™ Spinal System2018-03-08
Medtronic Sofamor Danek USA, Inc.
Navigated INFINITY™ Instruments2018-01-18
Medtronic Sofamor Danek USA, Inc.
ARTiC-L 3D Ti Spinal System With TiONIC Technology, ARTiC-XL 3D Ti Spinal System With TiONIC Technology2017-10-05
Medtronic Sofamor Danek USA, Inc.
INFINITY™ OCT System2017-08-21
Medtronic Sofamor Danek USA, Inc.
TRANSLACE™ Spinal Tethering System2017-05-16
MEDTRONIC SOFAMOR DANEK USA, INC
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments2017-04-14
Medtronic Sofamor Danek USA, Inc.
CD HORIZON® Spinal System2016-12-20
MEDTRONIC SOFAMOR DANEK USA, INC.
SOVEREIGN® Spinal System2016-12-14
MEDTRONIC SOFAMOR DANEK USA, INC.
CD HORIZON® Spinal System2016-11-16
Medtronic Sofamor Danek USA, Inc.
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 STEALTHS2016-02-18
Medtronic Sofamor Danek USA, Inc.
Medtronic Transportation/Sterilization Cassettes2016-01-20
MEDTRONIC SOFAMOR DANEK USA, INC.
CD HORIZON Spinal System, IPC POWEREASE System2015-12-30
MEDTRONIC SOFAMOR DANEK USA, INC
ATLANTIS Anterior Cervical Plate System2015-11-12
Medtronic Sofamor Danek USA, Inc.
CD HORIZON Spinal System2015-11-05
Medtronic Sofamor Danek USA, Inc.
ELEVATE Spinal System2015-06-09
MEDTRONIC SOFAMOR DANEK USA, INCORPORATED
CD HORIZON Growth Rod Conversion Set2015-02-25
MEDTRONIC SOFAMOR DANEK USA, INC
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments2015-02-13
MEDTRONIC SOFAMOR DANEK USA, INC
Navigated Vertex Select Instruments2015-02-12
MEDTRONIC SOFAMOR DANEK USA, INC.
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM2015-01-21

Latest Premarket Applications

PMAManufacturerDevice NameDate
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2019-11-29
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/Medtronic Interbody Fusion2019-11-29
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft/Medtronic Interbody Fusion2019-11-01
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft2019-11-01
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft and Medtronic Interbody Fusion2019-07-24
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2019-07-24
Medtronic Sofamor Danek USA, Inc.
Prestige LP Cervical Disc – Two Level2019-07-12
Medtronic Sofamor Danek USA, Inc.
Prestige LP Cervical Disc2019-04-26
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2019-01-15
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/Medtronic Interbody Fusion2019-01-15
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2018-11-09
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/medtronic Interbody Fusion Devise2018-11-09
Medtronic Sofamor Danek USA, Inc.
PRESTIGE LP Cervical Disc2018-09-27
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft2018-08-29
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion2018-08-29
Medtronic Sofamor Danek USA, Inc.
PRESTIGE LP Cervical Disc2018-02-13
Medtronic Sofamor Danek USA, Inc.
PRESTIGE: LP(TM) CERVICAL DISC2018-01-31
Medtronic Sofamor Danek USA, Inc.
BRYAN (TM) CERVICAL DISC2018-01-31
Medtronic Sofamor Danek USA, Inc.
INFUSE Bone Graft / LT-Cage Lumbar Tapered Fusion2017-12-13
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2017-12-13
Medtronic Sofamor Danek USA, Inc.
Infuse (R) Bone Graft2017-09-21
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2017-06-21
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/Medtronic Interbody Fusion2017-06-21
Medtronic Sofamor Danek USA, Inc.
PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS2017-04-03
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft2017-03-03
Medtronic Sofamor Danek USA, Inc.
Infuse Bone Graft/Medtronic Interbody Fusion2017-03-03
Medtronic Sofamor Danek USA, Inc.
INFUSE BONE GRAFT2017-02-16
Medtronic Sofamor Danek USA, Inc.
INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE2017-02-16
Medtronic Sofamor Danek USA, Inc.
PRESTIGE LP CERVICAL DISC2016-12-15
Medtronic Sofamor Danek USA, Inc.
INFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM2016-09-29

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.