Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Sofamor Danek, Inc. · Predicate Candidate Screening
99 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
201 days90th percentile
99clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek, Inc. | 2025-06-12 | 56 | 0 |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty | Medtronic Sofamor Danek, Inc. | 2025-01-17 | 49 | 0 |
| K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. | 2023-07-18 | 125 | 0 |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Medtronic Sofamor Danek, Inc. | 2014-09-05 | 60 | 0 |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | Medtronic Sofamor Danek, Inc. | 2014-07-09 | 141 | 0 |
| K140449 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2014-03-25 | 29 | 0 |
| K132897 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-12-11 | 86 | 0 |
| K133216 | CRESCENT SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-11-22 | 35 | 0 |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek, Inc. | 2013-09-26 | 28 | 0 |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEV | Medtronic Sofamor Danek, Inc. | 2013-09-23 | 90 | 0 |
| K123027 | CAPSTONE(R) SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-07-25 | 300 | 0 |
| K122037 | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICA | Medtronic Sofamor Danek, Inc. | 2013-03-22 | 254 | 0 |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | 2013-03-06 | 201 | 0 |
| K123691 | MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) | Medtronic Sofamor Danek, Inc. | 2013-01-31 | 59 | 0 |
| K122433 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-09-28 | 49 | 0 |
| K122591 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-09-18 | 25 | 0 |
| K121764 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-08-21 | 67 | 0 |
| K121191 | VERTEX RCCONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-06-29 | 71 | 0 |
| K112473 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-10-21 | 56 | 0 |
| K110063 | SOVEREIGN SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-10-04 | 267 | 0 |
| K111510 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-09-15 | 106 | 0 |
| K102886 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-01-26 | 118 | 0 |
| K102807 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2010-11-17 | 50 | 0 |
| K093058 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2009-10-26 | 26 | 0 |
| K092676 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2009-10-02 | 31 | 0 |
| K081950 | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | 2008-07-18 | 9 | 0 |
| K062254 | AXIS FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2008-06-16 | 682 | 0 |
| K062447 | TRAVERSE OCT SPINAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2007-10-15 | 419 | 0 |
| K070173 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2007-03-14 | 55 | 0 |
| K063100 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE | Medtronic Sofamor Danek, Inc. | 2007-02-23 | 136 | 3 |
| K062879 | TRAVERSE OCT SPINAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-12-22 | 87 | 0 |
| K062807 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-11-06 | 48 | 0 |
| K063083 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-11-06 | 27 | 0 |
| K061591 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-09-08 | 92 | 0 |
| K061938 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-08-09 | 30 | 0 |
| K061592 | MODIFICATION TO CD HORIZON SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-07-03 | 25 | 0 |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-06-06 | 144 | 0 |
| K050484 | BASIS SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-05-04 | 68 | 0 |
| K050439 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-03-24 | 30 | 0 |
| K042922 | VENTURE ANTERIOR CERVICAL PLATING SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-11-19 | 28 | 0 |
| K042453 | MODIFICATION TO EQUATION FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-10-07 | 27 | 0 |
| K042402 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-10-01 | 28 | 0 |
| K042025 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-08-25 | 28 | 4 |
| K040483 | EQUESTRA FLUID DELIVERY SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-07-23 | 149 | 0 |
| K041282 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-06-10 | 28 | 0 |
| K041217 | MODIFICATION TO BONE GRAFT WASHER | Medtronic Sofamor Danek, Inc. | 2004-05-28 | 18 | 0 |
| K040072 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-02-12 | 29 | 0 |
| K033495 | MODIFICATION TO EQUATION FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-12-03 | 28 | 0 |
| K031967 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-09-17 | 83 | 0 |
| K032578 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-09-17 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda