Data / Medical devices / China / Medtronic (Changzhou) Medical Devices Technology Co., Ltd
Medtronic (Changzhou) Medical Devices Technology Co., Ltd: FDA-registered device maker in Changzhou Jiangsu, China, 41 510(k) clearances
Medtronic (Changzhou) Medical Devices Technology Co., Ltd is registered with the FDA (registration 3005677016) in Changzhou Jiangsu, China. It lists 53 device types. The FDA files 41 510(k) clearances under its listings, the newest dated January 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005677016
- Address
- Building #3, 11 ChangJiang North Road, Xinbei District, Changzhou Jiangsu, China, 213022
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- February 15, 1978
- Registered through
- 2027
- Brand names listed
- , MOTORS, ARTHROSCOPE, ARTiC-L 3D Ti Spinal System with TiONIC Technology, Anatomic Peek, Anteralign Spinal System with Titan nanolOCk, Anteralign Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments, Anteralign Spinal system with Titan nanoLOCK Surface Technology, Aspen 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 |
|---|---|---|---|---|---|---|
| January 21, 2026 | K254165 | Infinity OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253129 | Infinity OCT System | NKG | 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 |
| September 29, 2022 | K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 25, 2022 | K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | 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 |
| May 24, 2021 | K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 10, 2020 | K201407 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | PML | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| August 26, 2019 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173125 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 2, 2017 | K172328 | SOVEREIGN Spinal System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 5, 2017 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 14, 2016 | K162680 | SOVEREIGN® Spinal System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 4, 2016 | K162494 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 7, 2016 | K153555 | EM ENT Navigated Suctions | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 13, 2015 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 21, 2015 | K141599 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | OVE | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 1, 2014 | K142450 | DIVERGENCE Anterior Cervical Fusion System | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 25, 2013 | K132639 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 9, 2013 | K123978 | CAPSTONE L SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 3, 2012 | K122862 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 9, 2012 | K120368 | CAPSTONE CONTROL SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 15, 2011 | K112444 | ANATOMIC PEEK CERVICAL FUSION SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danck USA, Inc. | accessdata.fda.gov |
| July 18, 2011 | K103731 | CAPSTONE R SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 17, 2010 | K102807 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| April 26, 2010 | K094025 | CRESCENT SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 17, 2009 | K091813 | INTREPID SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 29, 2008 | K083026 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 24, 2008 | K073291 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 1, 2007 | K071416 | PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 14, 2006 | K060719 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 28, 2005 | K052747 | MODIFICATION TO:CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 7, 2005 | K052261 | MODIFICATION TO: VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 2, 2005 | K050438 | STEALTHSTATION SYSTEM UPDATE | HAW | Substantially Equivalent | Medtronic Surgical Navigation Technologies | accessdata.fda.gov |
| November 24, 2000 | K002931 | METRX SYSTEM | HRX | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 27, 2000 | K002399 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | MNH | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
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Updated January 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.