Data / Medical devices / Germany / Medtronic Sofamor Danek Deggendorf GMBH
Medtronic Sofamor Danek Deggendorf GMBH: FDA-registered device maker in DEGGENDORF Bavaria, Germany, 64 510(k) clearances and 2 PMA approvals
Medtronic Sofamor Danek Deggendorf GMBH is registered with the FDA (registration 3011795235) in DEGGENDORF Bavaria, Germany. It lists 23 device types. The FDA files 64 510(k) clearances and 2 PMA approvals under its listings, the newest dated February 12, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011795235
- Address
- Ulrichsbergerstr. 17, DEGGENDORF Bavaria, Germany, 94469
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- December 12, 1992
- Registered through
- 2026
- Brand names listed
- Anatomic Peek, Anatomic Peek PTC Cervical Fusion System Cage, Aspen, Bard-Parker, CAPSTONE CONTROL PTC Spinal System, CAPSTONE CONTROL Spinal System, CAPSTONE PTC SPINAL SYSTEM, CAPSTONE PTC 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 |
|---|---|---|---|---|---|---|
| February 12, 2026 | K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| September 6, 2024 | K241164 | IB3D PL Spinal System | MAX | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) | accessdata.fda.gov |
| October 15, 2019 | K190840 | Medtronic Transportation / Sterilization Cassettes | KCT | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 3, 2019 | K191066 | CD Horizon Astute Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 6, 2019 | K190165 | Capstone Control Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182928 | CD Horizon Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 2, 2017 | K172328 | SOVEREIGN Spinal System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 26, 2017 | K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 19, 2017 | K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 21, 2017 | K163375 | INFINITY OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 6, 2017 | K171031 | CRESCENT Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 13, 2015 | K152277 | PIVOX(tm) Oblique Lateral Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, 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 |
| January 21, 2015 | K141599 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | OVE | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 9, 2014 | K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| April 28, 2014 | K133653 | ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 13, 2014 | K133205 | CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 20, 2013 | K133650 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132897 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| April 19, 2013 | K130335 | MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX | MQV | 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 |
| August 29, 2012 | K121760 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 26, 2012 | K121982 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 9, 2012 | K120368 | CAPSTONE CONTROL SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 17, 2012 | K113252 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 20, 2011 | K113528 | CLYDESDALE(R) SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 21, 2011 | K112405 | CLYDESDALES 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 |
| November 9, 2011 | K110562 | TELAMON PEEK SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 12, 2011 | K111264 | CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 4, 2011 | K110063 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 5, 2011 | K100967 | PERIMETER C SPINAL SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 30, 2010 | K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 25, 2010 | K100214 | CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE | ODP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 2, 2010 | K100175 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | 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 |
| September 29, 2009 | K090353 | PERIMETER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 14, 2009 | K090740 | MODIFICATION TO: TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| February 9, 2009 | K082918 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | MQV | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 9, 2009 | K082917 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | LYC | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 29, 2008 | K083026 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 15, 2008 | K073285 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 24, 2008 | K073291 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 10, 2008 | K080083 | INTREPID SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 14, 2007 | K070173 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 26, 2006 | K062133 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Spinal and Biologics Div | accessdata.fda.gov |
| August 14, 2006 | K062073 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 9, 2006 | K061938 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| April 14, 2006 | K060719 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 16, 2005 | K052931 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | 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 |
| January 7, 2005 | K043566 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 9, 2004 | K041197 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 7, 2004 | K033926 | HOURGLASS VERTEBRAL BODY SPACER | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 1, 2004 | K041556 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 24, 2004 | K041452 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 30, 2003 | K031780 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 18, 2003 | K030735 | MODIFIED VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 2, 2003 | K030736 | VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 25, 2003 | K030601 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 26, 2002 | K021791 | VERTE-STACK SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 7, 2002 | K012506 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | MQV | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 10, 2001 | K010528 | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK | JDK | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 2, 2002 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 90 | August 26, 2026 | accessdata.fda.gov |
| May 14, 1999 | P970015 | INTER FIX THREADED FUSION DEVICE | MAX | 22 | July 27, 2005 | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Spinal Vertebral Body Replacement Device
- All makers of Retractor
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Filler, Bone Void, Calcium Compound
Updated August 26, 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.