Medtronic Sofamor Danek USA, Inc.
Medtronic Sofamor Danek USA, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2026, with 85 FDA device recalls on record.
Top product codes for Medtronic Sofamor Danek USA, Inc.
FDA recalls by Medtronic Sofamor Danek USA, Inc.
10 most recent of 85- Z-0580-2026 — Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.
- Z-0165-2024 — Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
- Z-0164-2024 — Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
- Z-0161-2024 — Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
- Z-0167-2024 — Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
- Z-0162-2024 — Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
- Z-0163-2024 — Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
- Z-0166-2024 — Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
- Z-2524-2023 — Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
- Z-2363-2023 — CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Sofamor Danek USA, Inc.
1–100 of 173- K253011 — Catalyft PL Expandable Interbody System
- K261020 — Symmetrix L Spinal System
- K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
- K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
- K254165 — Infinity OCT System
- K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
- K253129 — Infinity OCT System
- K253335 — CD Horizon Spinal System
- K251444 — Endoskeleton Interbody Systems
- K251395 — The Rialto SI Fusion System
- K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K241992 — Catalyft LS Expandable Interbody System
- K243007 — CD Horizon Spinal System
- K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
- K233830 — OsteoCool 2.0 RF Ablation System
- K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
- K231090 — Zevo Anterior Cervical Plate System
- K231184 — CD Horizon Spinal System
- K223764 — INFINITY OCT System
- K223153 — Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
- K221646 — CD HORIZON ASTUTE SPINAL SYSTEM +7 more
- K222383 — Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition
- K221180 — Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
- K214011 — 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
- K212524 — Anteralign Spinal System with Titan nanoLOCK Surface Technology
- K212653 — Catalyft LS Expandable Interbody System
- K211958 — CD Horizon Spinal System
- K211441 — Navigated Anterolateral Disc Prep Instruments
- K211258 — 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
- K210425 — Catalyft PL Expandable Interbody System
- K203678 — CD HORIZON Spinal System
- K203291 — CD Horizon Spinal System Instruments
- K201407 — CD Horizon Spinal System
- K202328 — CD Horizon Spinal System
- K191788 — CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K192502 — 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
- K193011 — CD Horizon Fenestrated Screw Set
- K192336 — Navigated Anterolateral Disc Prep Instruments
- K190840 — Medtronic Transportation / Sterilization Cassettes
- K191066 — CD Horizon Astute Spinal System
- K191148 — Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set
- K191039 — Navigated T2 STRATOSPHERE Inserters and Navigated Templates
- K190959 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
- K190165 — Capstone Control Spinal System
- K183197 — PYRAMESH Implant System
- K182885 — 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
- K183510 — T2 STRATOSPHERE Expandable Corpectomy System
- K182497 — OsteoCool RF Ablation System
- K182928 — CD Horizon Spinal System
- K182121 — CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
- K182436 — POWEREASE System
- K181328 — T2 STRATOSPHERE Expandable Corpectomy System
- K182119 — CD HORIZON Spinal System
- K180700 — KYPHON HV-R Bone Cement
- K181111 — Navigated INFINITY Instruments
- K180851 — VERTEX Reconstruction System
- K173249 — CD HORIZON Spinal System
- K173338 — Navigated INFINITY Instruments
- K172328 — SOVEREIGN Spinal System
- K171689 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
- K171107 — CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
- K163375 — INFINITY OCT System
- K162212 — DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
- K163181 — TRANSLACE Spinal Tethering System
- K163581 — Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
- K163279 — Medtronic Transportation/Sterilization Cassettes
- K163301 — CD HORIZON® Spinal System
- K162680 — SOVEREIGN® Spinal System
- K162379 — CD HORIZON® Spinal System
- K162494 — CD HORIZON® Spinal System
- K160528 — ANATOMIC PEEK PTC Cervical Fusion System
- K160418 — PERIMETER Interbody Fusion Device
- K153438 — PERIMETER C (Titanium) Spinal System
- 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 Systems
- K153589 — CD HORIZON Spinal System
- K152241 — Medtronic Transportation/Sterilization Cassettes
- K153463 — CD HORIZON Spinal System, IPC POWEREASE System
- K152277 — PIVOX(tm) Oblique Lateral Spinal System
- K152623 — ATLANTIS Anterior Cervical Plate System
- K152248 — CD HORIZON Spinal System
- K152338 — VERTEX(r) Reconstruction System
- K152457 — CD HORIZON Spinal System
- K151172 — MASTERGRAFT Contain
- K151128 — CAPSTONE Spinal System, CLYDESDALE Spinal System
- K150231 — Navigated Disc Prep Instruments and CAPSTONE Trials
- K150135 — DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K142559 — ELEVATE Spinal System
- K142648 — SPINEDESIGN Spine Surgery Planning (Software Application)
- K143019 — CD HORIZON Spinal System, IPC POWEREASE System
- K143375 — CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
- K143569 — CD HORIZON Spinal System
- K143628 — Navigated Vertex Select Instruments
- K150178 — CD HORIZON SPINAL SYSTEM
- K143471 — VERTEX Reconstruction System
- K141599 — DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
- K141632 — ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
- K142591 — CD HORIZON Spinal System
- K143141 — CD HORIZON Spinal System
- K141604 — CD HORIZON SPINAL SYSTEM
- K142450 — DIVERGENCE Anterior Cervical Fusion System
Data sourced from openFDA. This site is unofficial and independent of the FDA.