Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Medtronic Sofamor Danek USA · Predicate Candidate Screening

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

67 daysmedian FDA review time

254 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K214010	Anteralign Spinal System with Titan nanoLOCK Surface Technol	Medtronic Sofamor Danek USA	2022-04-12	111
K170347	CD HORIZON™ Fenestrated Screw Set	Medtronic Sofamor Danek USA	2017-04-04	60
K133904	CD HORIZON SPINAL SYSTEM GROWTH ROD SET	Medtronic Sofamor Danek USA	2014-02-25	67
K132111	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek USA	2013-08-06	28
K131321	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek USA	2013-06-05	28
K123978	CAPSTONE L SPINAL SYSTEM	Medtronic Sofamor Danek USA	2013-04-09	104
K113642	PERIMETER INTERBODY FUSION DEVICE	Medtronic Sofamor Danek USA	2012-02-06	56
K110562	TELAMON PEEK SPINAL SYSTEM	Medtronic Sofamor Danek USA	2011-11-09	254
K111264	CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM	Medtronic Sofamor Danek USA	2011-10-12	161

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