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Medtronic Sofamor Danek USA, Inc.

191 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094)Medtronic Sofamor Danek USA, Inc.2025-03-19
INFUSE® Bone Graft (P000054/S074)Medtronic Sofamor Danek USA, Inc.2025-03-19
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S093)Medtronic Sofamor Danek USA, Inc.2024-11-06
INFUSE™ Bone Graft (P000054/S073)Medtronic Sofamor Danek USA, Inc.2024-11-06
Prestige LP (R) Cervical Disc (P090029/S021)Medtronic Sofamor Danek USA, Inc.2024-08-09
Prestige LP (R) Cervical Disc (P090029/S020)Medtronic Sofamor Danek USA, Inc.2024-05-01
Prestige LP Cervical Disc (P090029/S018)Medtronic Sofamor Danek USA, Inc.2024-02-21
Prestige LP® Cervical Disc (P090029/S019)Medtronic Sofamor Danek USA, Inc.2023-10-26
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S091)Medtronic Sofamor Danek USA, Inc.2023-10-06
INFUSE™ Bone Graft (P000054/S071)Medtronic Sofamor Danek USA, Inc.2023-10-06
Infuse Bone Graft (P000058/S088)Medtronic Sofamor Danek USA, Inc.2023-08-25
INFUSE™ Bone Graft, Medtronic Interbody Fusion Device (P000058/S090)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft (P000054/S069)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft, Medtronic Interbody Fusion Device (P000058/S089)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft (P000054/S070)Medtronic Sofamor Danek USA, Inc.2023-08-21
Prestige LP® Cervical Disc (P090029/S017)Medtronic Sofamor Danek USA, Inc.2023-05-24
Infuse™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S087)Medtronic Sofamor Danek USA, Inc.2022-08-09
Infuse™ Bone Graft (P000054/S068)Medtronic Sofamor Danek USA, Inc.2022-08-09
Infuse Bone Graft (P000054/S067)Medtronic Sofamor Danek USA, Inc.2022-06-09
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S086)Medtronic Sofamor Danek USA, Inc.2022-06-08
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S081)Medtronic Sofamor Danek USA, Inc.2022-02-18
Infuse Bone Graft (P000054/S062)Medtronic Sofamor Danek USA, Inc.2022-02-18
INFUSE™ BoneGraft/Medtronic lnterbody Fusion Device (P000058/S085)Medtronic Sofamor Danek USA, Inc.2022-02-17
INFUSE™ Bone Graft (P000054/S066)Medtronic Sofamor Danek USA, Inc.2022-02-17
Infuse Bone Graft (P000054/S060)Medtronic Sofamor Danek USA, Inc.2021-11-08
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S079)Medtronic Sofamor Danek USA, Inc.2021-11-08
INFUSE Bone Graft (P000054/S065)Medtronic Sofamor Danek USA, Inc.2021-04-05
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S084)Medtronic Sofamor Danek USA, Inc.2021-04-05
Infuse Bone Graft (P000054/S064)Medtronic Sofamor Danek USA, Inc.2021-02-05
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S083)Medtronic Sofamor Danek USA, Inc.2021-02-05
Infuse Bone Graft (P000054/S061)Medtronic Sofamor Danek USA, Inc.2020-12-30
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S080)Medtronic Sofamor Danek USA, Inc.2020-12-30
PRESTIGE LP Cervical Disc (P090029/S015)Medtronic Sofamor Danek USA, Inc.2020-12-01
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S082)Medtronic Sofamor Danek USA, Inc.2020-08-27
Infuse Bone Graft (P000054/S063)Medtronic Sofamor Danek USA, Inc.2020-08-27
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S078)Medtronic Sofamor Danek USA, Inc.2020-07-10
Infuse Bone Graft (P000054/S059)Medtronic Sofamor Danek USA, Inc.2020-07-10
PRESTIGE LP Cervical Disc (P090029/S014)Medtronic Sofamor Danek USA, Inc.2020-04-15
Prestiege LP Cervical Disc - Two-Level (P090029/S013)Medtronic Sofamor Danek USA, Inc.2020-03-06
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S073)Medtronic Sofamor Danek USA, Inc.2020-02-04
Infuse Bone Graft (P000054/S054)Medtronic Sofamor Danek USA, Inc.2020-02-04
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S074)Medtronic Sofamor Danek USA, Inc.2019-12-13
Infuse Bone Graft (P000054/S055)Medtronic Sofamor Danek USA, Inc.2019-12-13
INFUSE Bone Graft (P000054/S058)Medtronic Sofamor Danek USA, Inc.2019-12-04
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S077)Medtronic Sofamor Danek USA, Inc.2019-12-04
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S076)Medtronic Sofamor Danek USA, Inc.2019-11-29
Infuse Bone Graft (P000054/S057)Medtronic Sofamor Danek USA, Inc.2019-11-29
INFUSE Bone Graft (P000054/S056)Medtronic Sofamor Danek USA, Inc.2019-11-01
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S075)Medtronic Sofamor Danek USA, Inc.2019-11-01
Infuse Bone Graft and Medtronic Interbody Fusion Device (P000058/S072)Medtronic Sofamor Danek USA, Inc.2019-07-24
Infuse Bone Graft (P000054/S053)Medtronic Sofamor Danek USA, Inc.2019-07-24
Prestige LP Cervical Disc – Two Level (P090029/S012)Medtronic Sofamor Danek USA, Inc.2019-07-12
Prestige LP Cervical Disc (P090029/S011)Medtronic Sofamor Danek USA, Inc.2019-04-26
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S071)Medtronic Sofamor Danek USA, Inc.2019-01-15
Infuse Bone Graft (P000054/S052)Medtronic Sofamor Danek USA, Inc.2019-01-15
Infuse Bone Graft/medtronic Interbody Fusion Devise (P000058/S070)Medtronic Sofamor Danek USA, Inc.2018-11-09
Infuse Bone Graft (P000054/S051)Medtronic Sofamor Danek USA, Inc.2018-11-09
PRESTIGE LP Cervical Disc (P090029/S010)Medtronic Sofamor Danek USA, Inc.2018-09-27
INFUSE Bone Graft (P000054/S050)Medtronic Sofamor Danek USA, Inc.2018-08-29
INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion Device (P000058/S069)Medtronic Sofamor Danek USA, Inc.2018-08-29
PRESTIGE LP Cervical Disc (P090029/S009)Medtronic Sofamor Danek USA, Inc.2018-02-13
PRESTIGE: LP(TM) CERVICAL DISC (P090029/S008)Medtronic Sofamor Danek USA, Inc.2018-01-31
INFUSE Bone Graft / LT-Cage Lumbar Tapered Fusion Device (P000058/S068)Medtronic Sofamor Danek USA, Inc.2017-12-13
Infuse Bone Graft (P000054/S049)Medtronic Sofamor Danek USA, Inc.2017-12-13
Infuse (R) Bone Graft (P000058/S065)Medtronic Sofamor Danek USA, Inc.2017-09-21
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S067)Medtronic Sofamor Danek USA, Inc.2017-06-21
Infuse Bone Graft (P000054/S048)Medtronic Sofamor Danek USA, Inc.2017-06-21
PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS (P090029/S007)Medtronic Sofamor Danek USA, Inc.2017-04-03
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S064)Medtronic Sofamor Danek USA, Inc.2017-03-03
Infuse Bone Graft (P000054/S046)Medtronic Sofamor Danek USA, Inc.2017-03-03
INFUSE BONE GRAFT (P000054/S045)Medtronic Sofamor Danek USA, Inc.2017-02-16
INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE (P000058/S063)Medtronic Sofamor Danek USA, Inc.2017-02-16
PRESTIGE LP CERVICAL DISC (P090029/S006)Medtronic Sofamor Danek USA, Inc.2016-12-15
INFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM (P000058/S062)Medtronic Sofamor Danek USA, Inc.2016-09-29
INFUSE BONE GRAFT (P000054/S044)Medtronic Sofamor Danek USA, Inc.2016-09-16
INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE (P000058/S060)Medtronic Sofamor Danek USA, Inc.2016-09-16
PRESTIGE LP CERVICAL DISC SYSTEM (P090029/S005)Medtronic Sofamor Danek USA, Inc.2016-08-11
LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS (P000058/S061)Medtronic Sofamor Danek USA, Inc.2016-08-11
PRESTIGE LP(TM) CERVICAL DISC (P090029/S003)Medtronic Sofamor Danek USA, Inc.2016-07-07
PRESTIGE LP CERVICAL DISC (P090029/S004)Medtronic Sofamor Danek USA, Inc.2016-06-07
PRESTIGE(R) LP CERVICAL DISC (P090029/S002)Medtronic Sofamor Danek USA, Inc.2016-03-11
INFUSE(R) BONE GRAFT (P000058/S059)Medtronic Sofamor Danek USA, Inc.2015-12-04
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S056)Medtronic Sofamor Danek USA, Inc.2015-07-15
INFUSE BONE GRAFT (P000054/S042)Medtronic Sofamor Danek USA, Inc.2015-07-15
INFUSE BONE GRAFT (P000054/S043)Medtronic Sofamor Danek USA, Inc.2015-04-24
INFUSE BONE GRAFT LUMBAR TAPERED FUSION DEVICE (P000058/S057)Medtronic Sofamor Danek USA, Inc.2015-04-24
PRESTIGE (R) LP CERVICAL DISC (P090029/S001)Medtronic Sofamor Danek USA, Inc.2015-04-06
INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S058)Medtronic Sofamor Danek USA, Inc.2015-01-27
PRESTIGE LP CERVICAL DISC (P090029)Medtronic Sofamor Danek USA, Inc.2014-07-24
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S037)Medtronic Sofamor Danek USA, Inc.2014-07-24
INFUSE BONE GRAFT (P000054/S040)Medtronic Sofamor Danek USA, Inc.2013-12-06
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S054)Medtronic Sofamor Danek USA, Inc.2013-12-06
INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S047)Medtronic Sofamor Danek USA, Inc.2013-08-30
INFUSE BONE GRAFT (P000054/S032)Medtronic Sofamor Danek USA, Inc.2013-08-30
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S049)Medtronic Sofamor Danek USA, Inc.2013-08-01
INFUSE BONE GRAFT (P000054/S034)Medtronic Sofamor Danek USA, Inc.2013-08-01
INFUSE BONE GRAFT (P000054/S039)Medtronic Sofamor Danek USA, Inc.2013-05-31
INFUSE BONE GRAFT (P000054/S038)Medtronic Sofamor Danek USA, Inc.2013-03-27
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S053)Medtronic Sofamor Danek USA, Inc.2013-03-27
INFUSE BONE GRAFT (P000054/S037)Medtronic Sofamor Danek USA, Inc.2013-02-13
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