Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medtronic Sofamor Danek · Predicate Candidate Screening

154 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

65 daysmedian FDA review time

182 days90th percentile

154clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212428	Centerpiece Plate Fixation System	Medtronic Sofamor Danek	2021-12-13	131	0
K201267	Adaptix Interbody System with Titan nanoLOCK Surface Technol	Medtronic Sofamor Danek	2020-08-26	106	0
K173125	T2 STRATOSPHERE™ Expandable Corpectomy System	Medtronic Sofamor Danek	2017-12-20	82	0
K172199	ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT	Medtronic Sofamor Danek	2017-09-19	60	0
K171031	CRESCENT™ Spinal System	Medtronic Sofamor Danek	2017-07-06	91	0
K171468	FUSE Spinal System	Medtronic Sofamor Danek	2017-06-13	26	0
K170679	CD HORIZON® Spinal System, Medtronic Reusable Instruments fo	Medtronic Sofamor Danek	2017-05-11	66	0
K161210	RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments	Medtronic Sofamor Danek	2016-08-12	106	0
K153373	CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal S	Medtronic Sofamor Danek	2016-01-19	57	0
K140276	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2014-03-13	38	0
K123246	CD HORIZON SPIRE Z SPINAL SYSTEM	Medtronic Sofamor Danek	2012-11-16	30	0
K121982	SOVEREIGN SPINAL SYSTEM	Medtronic Sofamor Danek	2012-07-26	20	0
K110472	SI-FIX SACROILIAC JOINT FUSION SYSTEM	Medtronic Sofamor Danek	2012-05-29	466	0
K113529	CD HORIZON VOYAGER SPINAL SYSTEM	Medtronic Sofamor Danek	2012-02-09	71	0
K113252	PEEK PREVAIL CERVICAL INTERBODY DEVICE	Medtronic Sofamor Danek	2012-01-17	75	0
K111457	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2011-09-15	112	0
K111525	PERIMETER INTERBODY FUSION DEVICE	Medtronic Sofamor Danek	2011-08-24	84	0
K103731	CAPSTONE R SPINAL SYSTEM	Medtronic Sofamor Danek	2011-07-18	208	0
K110676	TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2011-05-23	74	0
K103049	TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2010-12-23	69	0
K101772	TSRH(R) SPINAL SYSTEM	Medtronic Sofamor Danek	2010-09-30	98	0
K091445	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2010-09-27	500	0
K101168	LEGEND POWER ADAPTER MODEL: 6475000	Medtronic Sofamor Danek	2010-08-24	120	0
K094042	PEEK PREVAIL CERVICAL INTERBODY DEVICE	Medtronic Sofamor Danek	2010-06-30	182	0
K100214	CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE	Medtronic Sofamor Danek	2010-06-25	151	0
K100175	CLYDESDALE SPINAL SYSTEM	Medtronic Sofamor Danek	2010-06-02	132	0
K091797	TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2010-04-30	317	0
K094025	CRESCENT SPINAL SYSTEM	Medtronic Sofamor Danek	2010-04-26	117	0
K093434	VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTIO	Medtronic Sofamor Danek	2009-12-02	28	0
K091813	INTREPID SPINAL SYSTEM	Medtronic Sofamor Danek	2009-11-17	152	0
K090353	PERIMETER INTERBODY FUSION DEVICE	Medtronic Sofamor Danek	2009-09-29	230	0
K090740	MODIFICATION TO: TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2009-08-14	147	0
K091442	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2009-07-15	61	0
K082166	MASTERGRAFT STRIP	Medtronic Sofamor Danek	2009-06-02	306	0
K090390	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2009-05-15	87	0
K090714	VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION S	Medtronic Sofamor Danek	2009-04-17	30	0
K082918	MASTERGRAFT RESORBABLE CERAMIC GRANULES	Medtronic Sofamor Danek	2009-02-09	132	0
K082917	MASTERGRAFT RESORBABLE CERAMIC GRANULES	Medtronic Sofamor Danek	2009-01-09	101	0
K083026	CLYDESDALE SPINAL SYSTEM	Medtronic Sofamor Danek	2008-12-29	80	0
K082002	PROGENIX PLUS	Medtronic Sofamor Danek	2008-11-24	133	0
K081080	TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2008-11-21	219	0
K083071	VERTEX RECONSTRUCTION SYSTEM	Medtronic Sofamor Danek	2008-11-14	30	1
K082463	PROGENIX	Medtronic Sofamor Danek	2008-11-10	75	0
K082236	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2008-10-10	64	0
K081784	MASTERGRAFT PUTTY	Medtronic Sofamor Danek	2008-09-17	85	0
K082342	MODIFICATION TO CAPSTONE SPINAL SYSTEM	Medtronic Sofamor Danek	2008-09-12	28	0
K082112	T2 XVBR SPINAL SYSTEM	Medtronic Sofamor Danek	2008-08-27	30	0
K081038	ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM	Medtronic Sofamor Danek	2008-08-15	126	3
K081297	VERTEX RECONSTRUCTION SYSTEM	Medtronic Sofamor Danek	2008-06-11	35	0
K080462	PROGENIX DBM PUTTY	Medtronic Sofamor Danek	2008-05-13	83	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