Data / Medical devices / United States / Titan Spine, a Division of Medtronic
Titan Spine, a Division of Medtronic: FDA-registered device maker in Milwaukee, WI, United States, 28 510(k) clearances
Titan Spine, a Division of Medtronic is registered with the FDA (registration 3011577940) in Milwaukee, WI, United States. It lists 30 device types. The FDA files 28 510(k) clearances under its listings, the newest dated April 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011577940
- Address
- 8347 N Steven Rd, Milwaukee, WI, United States, 53223
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 12, 1992
- Registered through
- 2026
- Brand names listed
- Adaptix Interbody System with Titan nanoLock Surface Technology, Anteralign Spinal System with Titan nanolOCk, Anteralign Spinal system with Titan nanoLOCK Surface Technology, BIT DRILLS, CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2, CD Horizon Spinal System, CD Horizon ModuLeX Fenestrated Screw Set, CD Horizon ModuLeX Spinal System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 27, 2024 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 23, 2023 | K223494 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 12, 2022 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| December 8, 2021 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 26, 2020 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 8, 2020 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| October 15, 2019 | K190840 | Medtronic Transportation / Sterilization Cassettes | KCT | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 29, 2019 | K192054 | Endoskeleton TAS Plate | OVD | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| August 16, 2019 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | ODP | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| August 6, 2019 | K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | ODP | Substantially Equivalent | Titan Spine, Inc. | accessdata.fda.gov |
| February 13, 2018 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| July 6, 2017 | K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| April 13, 2017 | K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| December 14, 2015 | K153122 | Endoskeleton(r) TCS System | OVE | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| October 9, 2015 | K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| January 28, 2015 | K142940 | Endoskeleton TCS System | OVE | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| October 27, 2014 | K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| July 2, 2014 | K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| September 9, 2011 | K111626 | ENDOSKELETON(R) TAS | OVD | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| November 17, 2010 | K102807 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| November 5, 2010 | K102067 | ENDOSKELETON TO | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| July 29, 2010 | K100889 | ENDOSKELETON TC | ODP | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| April 15, 2009 | K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| June 17, 2008 | K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | MAX | Substantially Equivalent | Titan Spine, LLC | accessdata.fda.gov |
| August 21, 2007 | K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | GXZ | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| December 8, 2003 | K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | Orthovita, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Spinal Vertebral Body Replacement Device
Updated April 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.