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Medtronic Sofamor Danek USA, Inc.

173 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Catalyft PL Expandable Interbody System (K253011)Medtronic Sofamor Danek USA, Inc.2026-07-17
Symmetrix™ L Spinal System (K261020)Medtronic Sofamor Danek USA, Inc.2026-07-14
OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (K253656)Medtronic Sofamor Danek USA, Inc.2026-06-05
CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (K260216)Medtronic Sofamor Danek USA, Inc.2026-04-21
Infinity™ OCT System (K254165)Medtronic Sofamor Danek USA, Inc.2026-01-21
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (K253941)Medtronic Sofamor Danek USA, Inc.2026-01-07
Infinity™ OCT System (K253129)Medtronic Sofamor Danek USA, Inc.2025-10-24
CD Horizon™ Spinal System (K253335)Medtronic Sofamor Danek USA, Inc.2025-10-24
Endoskeleton™ Interbody Systems (K251444)Medtronic Sofamor Danek USA, Inc.2025-09-04
The Rialto™ SI Fusion System (K251395)Medtronic Sofamor Danek USA, Inc.2025-06-26
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669)Medtronic Sofamor Danek USA, Inc.2025-04-22
Catalyft™ LS Expandable Interbody System (K241992)Medtronic Sofamor Danek USA, Inc.2024-10-28
CD Horizon™ Spinal System (K243007)Medtronic Sofamor Danek USA, Inc.2024-10-23
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (K233951)Medtronic Sofamor Danek USA, Inc.2024-03-27
OsteoCool™ 2.0 RF Ablation System (K233830)Medtronic Sofamor Danek USA, Inc.2024-02-28
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) (K232141)Medtronic Sofamor Danek USA, Inc.2023-08-16
Zevo Anterior Cervical Plate System (K231090)Medtronic Sofamor Danek USA, Inc.2023-06-15
CD Horizon™ Spinal System (K231184)Medtronic Sofamor Danek USA, Inc.2023-05-26
INFINITY OCT System (K223764)Medtronic Sofamor Danek USA, Inc.2023-01-11
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology (K223153)Medtronic Sofamor Danek USA, Inc.2022-12-16
CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (K221646)Medtronic Sofamor Danek USA, Inc.2022-10-04
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition (K222383)Medtronic Sofamor Danek USA, Inc.2022-09-29
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments (K221180)Medtronic Sofamor Danek USA, Inc.2022-05-25
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers (K214011)Medtronic Sofamor Danek USA, Inc.2022-02-09
Anteralign Spinal System with Titan nanoLOCK Surface Technology (K212524)Medtronic Sofamor Danek USA, Inc.2021-12-08
Catalyft LS Expandable Interbody System (K212653)Medtronic Sofamor Danek USA, Inc.2021-11-19
CD Horizon Spinal System (K211958)Medtronic Sofamor Danek USA, Inc.2021-07-21
Navigated Anterolateral Disc Prep Instruments (K211441)Medtronic Sofamor Danek USA, Inc.2021-06-09
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (K211258)Medtronic Sofamor Danek USA, Inc.2021-05-26
Catalyft PL Expandable Interbody System (K210425)Medtronic Sofamor Danek USA, Inc.2021-05-24
CD HORIZON™ Spinal System (K203678)Medtronic Sofamor Danek USA, Inc.2021-01-15
CD Horizon Spinal System Instruments (K203291)Medtronic Sofamor Danek USA, Inc.2020-12-08
CD Horizon™ Spinal System (K201407)Medtronic Sofamor Danek USA, Inc.2020-09-10
CD Horizon Spinal System (K202328)Medtronic Sofamor Danek USA, Inc.2020-09-08
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K191788)Medtronic Sofamor Danek USA, Inc.2020-03-23
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™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (K192502)Medtronic Sofamor Danek USA, Inc.2020-01-22
CD Horizon™ Fenestrated Screw Set (K193011)Medtronic Sofamor Danek USA, Inc.2020-01-10
Navigated Anterolateral Disc Prep Instruments (K192336)Medtronic Sofamor Danek USA, Inc.2019-11-22
Medtronic Transportation / Sterilization Cassettes (K190840)Medtronic Sofamor Danek USA, Inc.2019-10-15
CD Horizon™ Astute™ Spinal System (K191066)Medtronic Sofamor Danek USA, Inc.2019-10-03
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (K191148)Medtronic Sofamor Danek USA, Inc.2019-09-12
Navigated T2 STRATOSPHERE Inserters and Navigated Templates (K191039)Medtronic Sofamor Danek USA, Inc.2019-08-26
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K190959)Medtronic Sofamor Danek USA, Inc.2019-07-03
Capstone Control™ Spinal System (K190165)Medtronic Sofamor Danek USA, Inc.2019-05-06
PYRAMESH™ Implant System (K183197)Medtronic Sofamor Danek USA, Inc.2019-04-04
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 System (K182885)Medtronic Sofamor Danek USA, Inc.2019-02-06
T2 STRATOSPHERE Expandable Corpectomy System (K183510)Medtronic Sofamor Danek USA, Inc.2019-01-16
OsteoCool RF Ablation System (K182497)Medtronic Sofamor Danek USA, Inc.2019-01-15
CD Horizon™ Spinal System (K182928)Medtronic Sofamor Danek USA, Inc.2019-01-11
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition (K182121)Medtronic Sofamor Danek USA, Inc.2018-11-02
POWEREASE System (K182436)Medtronic Sofamor Danek USA, Inc.2018-10-04
T2 STRATOSPHERE™ Expandable Corpectomy System (K181328)Medtronic Sofamor Danek USA, Inc.2018-09-19
CD HORIZON™ Spinal System (K182119)Medtronic Sofamor Danek USA, Inc.2018-08-29
KYPHON HV-R Bone Cement (K180700)Medtronic Sofamor Danek USA, Inc.2018-05-18
Navigated INFINITY Instruments (K181111)Medtronic Sofamor Danek USA, Inc.2018-05-17
VERTEX™ Reconstruction System (K180851)Medtronic Sofamor Danek USA, Inc.2018-04-18
CD HORIZON™ Spinal System (K173249)Medtronic Sofamor Danek USA, Inc.2018-03-08
Navigated INFINITY™ Instruments (K173338)Medtronic Sofamor Danek USA, Inc.2018-01-18
SOVEREIGN™ Spinal System (K172328)Medtronic Sofamor Danek USA, Inc.2017-11-02
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K171689)Medtronic Sofamor Danek USA, Inc.2017-10-05
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System (K171107)Medtronic Sofamor Danek USA, Inc.2017-09-26
INFINITY™ OCT System (K163375)Medtronic Sofamor Danek USA, Inc.2017-08-21
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM (K162212)Medtronic Sofamor Danek USA, Inc.2017-05-19
TRANSLACE™ Spinal Tethering System (K163181)Medtronic Sofamor Danek USA, Inc.2017-05-16
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments (K163581)Medtronic Sofamor Danek USA, Inc.2017-04-14
Medtronic Transportation/Sterilization Cassettes (K163279)Medtronic Sofamor Danek USA, Inc.2017-02-23
CD HORIZON® Spinal System (K163301)Medtronic Sofamor Danek USA, Inc.2016-12-20
SOVEREIGN® Spinal System (K162680)Medtronic Sofamor Danek USA, Inc.2016-12-14
CD HORIZON® Spinal System (K162379)Medtronic Sofamor Danek USA, Inc.2016-11-16
CD HORIZON® Spinal System (K162494)Medtronic Sofamor Danek USA, Inc.2016-10-04
ANATOMIC PEEK PTC Cervical Fusion System (K160528)Medtronic Sofamor Danek USA, Inc.2016-03-28
PERIMETER Interbody Fusion Device (K160418)Medtronic Sofamor Danek USA, Inc.2016-03-07
PERIMETER C (Titanium) Spinal System (K153438)Medtronic Sofamor Danek USA, Inc.2016-03-02
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 Systems (K153442)Medtronic Sofamor Danek USA, Inc.2016-02-18
CD HORIZON Spinal System (K153589)Medtronic Sofamor Danek USA, Inc.2016-02-10
Medtronic Transportation/Sterilization Cassettes (K152241)Medtronic Sofamor Danek USA, Inc.2016-01-20
CD HORIZON Spinal System, IPC POWEREASE System (K153463)Medtronic Sofamor Danek USA, Inc.2015-12-30
PIVOX(tm) Oblique Lateral Spinal System (K152277)Medtronic Sofamor Danek USA, Inc.2015-11-13
ATLANTIS Anterior Cervical Plate System (K152623)Medtronic Sofamor Danek USA, Inc.2015-11-12
CD HORIZON Spinal System (K152248)Medtronic Sofamor Danek USA, Inc.2015-11-05
VERTEX(r) Reconstruction System (K152338)Medtronic Sofamor Danek USA, Inc.2015-10-28
CD HORIZON Spinal System (K152457)Medtronic Sofamor Danek USA, Inc.2015-10-27
MASTERGRAFT Contain (K151172)Medtronic Sofamor Danek USA, Inc.2015-08-14
CAPSTONE Spinal System, CLYDESDALE Spinal System (K151128)Medtronic Sofamor Danek USA, Inc.2015-08-06
Navigated Disc Prep Instruments and CAPSTONE Trials (K150231)Medtronic Sofamor Danek USA, Inc.2015-06-16
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K150135)Medtronic Sofamor Danek USA, Inc.2015-06-11
ELEVATE Spinal System (K142559)Medtronic Sofamor Danek USA, Inc.2015-06-09
SPINEDESIGN Spine Surgery Planning (Software Application) (K142648)Medtronic Sofamor Danek USA, Inc.2015-05-22
CD HORIZON Spinal System, IPC POWEREASE System (K143019)Medtronic Sofamor Danek USA, Inc.2015-04-08
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments (K143375)Medtronic Sofamor Danek USA, Inc.2015-02-13
CD HORIZON Spinal System (K143569)Medtronic Sofamor Danek USA, Inc.2015-02-12
Navigated Vertex Select Instruments (K143628)Medtronic Sofamor Danek USA, Inc.2015-02-12
CD HORIZON SPINAL SYSTEM (K150178)Medtronic Sofamor Danek USA, Inc.2015-02-11
VERTEX Reconstruction System (K143471)Medtronic Sofamor Danek USA, Inc.2015-02-06
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM (K141599)Medtronic Sofamor Danek USA, Inc.2015-01-21
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM (K141632)Medtronic Sofamor Danek USA, Inc.2014-12-04
CD HORIZON Spinal System (K143141)Medtronic Sofamor Danek USA, Inc.2014-12-01
CD HORIZON Spinal System (K142591)Medtronic Sofamor Danek USA, Inc.2014-12-01
CD HORIZON SPINAL SYSTEM (K141604)Medtronic Sofamor Danek USA, Inc.2014-10-21
DIVERGENCE Anterior Cervical Fusion System (K142450)Medtronic Sofamor Danek USA, Inc.2014-10-01
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