Medtronic Sofamor Danek
Memphis, TN, US
Medtronic Sofamor Danek appears in FDA device records in Memphis, TN. FDA records list 253 510(k) clearances between and , 26 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 253
- PMA records
- 26
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 253FDA records hold 253 510(k) clearances for Medtronic Sofamor Danek between 2000 and 2025. The busiest year on record is 2004, with 35. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 10 |
| 2001 | 18 |
| 2002 | 25 |
| 2003 | 23 |
| 2004 | 35 |
| 2005 | 26 |
| 2006 | 22 |
| 2007 | 14 |
| 2008 | 17 |
| 2009 | 12 |
| 2010 | 10 |
| 2011 | 8 |
| 2012 | 9 |
| 2013 | 8 |
| 2014 | 4 |
| 2016 | 2 |
| 2017 | 5 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | MQV | Substantially Equivalent | |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | MQV | Substantially Equivalent | |
| K230716 | Robotic Graft Delivery Instruments | OLO | Substantially Equivalent | |
| K212428 | Centerpiece Plate Fixation System | NQW | Substantially Equivalent | |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | |
| K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | MQP | Substantially Equivalent | |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | Substantially Equivalent | |
| K171031 | CRESCENT™ Spinal System | MAX | Substantially Equivalent | |
| K171468 | FUSE Spinal System | MAX | Substantially Equivalent | |
| 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 | |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | OUR | Substantially Equivalent | |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device | ODP | Substantially Equivalent | |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | MQV | Substantially Equivalent | |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | KWQ | Substantially Equivalent | |
| K140449 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K140276 | CD HORIZON SPINAL SYSTEM | OSH | Substantially Equivalent | |
| K132897 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K133216 | CRESCENT SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | MQP | Substantially Equivalent | |
| K123027 | CAPSTONE(R) SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K122037 | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST | MAX | Substantially Equivalent | |
| K122513 | CLEARED UNDER GRAFTON II EDBM | MBP | Substantially Equivalent | |
| K123691 | MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) | MQV | Substantially Equivalent | |
| K123246 | CD HORIZON SPIRE Z SPINAL SYSTEM | NKB | Unknown | |
| K122433 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K122591 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K121764 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K121982 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | |
| K121191 | VERTEX RCCONSTRUCTION SYSTEM | KWP | Substantially Equivalent | |
| K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | |
| K113529 | CD HORIZON VOYAGER SPINAL SYSTEM | NKB | Unknown | |
| K113252 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | |
| K112473 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K110063 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | |
| K111510 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K111457 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K111525 | PERIMETER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K103731 | CAPSTONE R SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K110676 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K102886 | CD HORIZON SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K103049 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K102807 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K101772 | TSRH(R) SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K091445 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | |
| K101168 | LEGEND POWER ADAPTER MODEL: 6475000 | HBB | Substantially Equivalent | |
| K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | |
| K100214 | CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K100175 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | |
| K091797 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- NUNBone Grafting Material, Human Source
- LYCBone Grafting Material, Synthetic
- NDNCement, Bone, Vertebroplasty
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HBBMotor, Drill, Pneumatic
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NQPPosterior Metal/Polymer Spinal System, Fusion
- JDKProsthesis, Hip, Cement Restrictor
- MJOProsthesis, Intervertebral Disc
- NQOProsthesis, Spinous Process Spacer/Plate
- GADRetractor
- OURSacroiliac Joint Fixation
- MQPSpinal Vertebral Body Replacement Device
- JDRStaple, Fixation, Bone
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain