Medtronic Sofamor Danek USA, Inc

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek USA, Inc. 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
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ S2020-01-22
Medtronic Sofamor Danek USA, Inc.
CD Horizon™ Fenestrated Screw Set2020-01-10
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.
OsteoCool RF Ablation System2019-01-15
Medtronic Sofamor Danek USA, Inc.
CD Horizon™ Spinal System2019-01-11
Medtronic Sofamor Danek USA, Inc.
CD HORIZON Spinal System Instruments For Use With MAZOR X Stealth Edition2018-11-02
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.
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System2017-09-26
Medtronic Sofamor Danek USA, Inc.
INFINITY™ OCT System2017-08-21
MEDTRONIC SOFAMOR DANEK USA, INC.
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM2017-05-19
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
CD HORIZON™ Fenestrated Screw Set2017-04-04
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 System2016-10-04
Medtronic Sofamor Danek USA, Inc
PERIMETER Interbody Fusion Device2016-03-07

Latest Premarket Applications

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

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

Related Finance Registrations

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