Medtronic Sofamor Danek

FDA 510(k) & PMA Approved Devices — 153 products

Total Devices153

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K212428	Centerpiece Plate Fixation System	NQW	2021-12-13	View
510(k)	K201267	Adaptix Interbody System with Titan nanoLOCK Surface Technology	MAX	2020-08-26	View
510(k)	K173125	T2 STRATOSPHERE™ Expandable Corpectomy System	MQP	2017-12-20	View
510(k)	K172199	ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium	MAX	2017-09-19	View
510(k)	K171031	CRESCENT™ Spinal System	MAX	2017-07-06	View
510(k)	K171468	FUSE Spinal System	MAX	2017-06-13	View
510(k)	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	2017-05-11	View
510(k)	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	2016-08-12	View
510(k)	K153373	CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device	ODP	2016-01-19	View
510(k)	K123246	CD HORIZON SPIRE Z SPINAL SYSTEM	NKB	2012-11-16	View
510(k)	K121982	SOVEREIGN SPINAL SYSTEM	OVD	2012-07-26	View
510(k)	K110472	SI-FIX SACROILIAC JOINT FUSION SYSTEM	OUR	2012-05-29	View
510(k)	K113529	CD HORIZON VOYAGER SPINAL SYSTEM	NKB	2012-02-09	View
510(k)	K113252	PEEK PREVAIL CERVICAL INTERBODY DEVICE	OVE	2012-01-17	View
510(k)	K111457	CD HORIZON SPINAL SYSTEM	NKB	2011-09-15	View
510(k)	K111525	PERIMETER INTERBODY FUSION DEVICE	MAX	2011-08-24	View
510(k)	K103731	CAPSTONE R SPINAL SYSTEM	MAX	2011-07-18	View
510(k)	K110676	TSRH SPINAL SYSTEM	NKB	2011-05-23	View
510(k)	K103049	TSRH SPINAL SYSTEM	NKB	2010-12-23	View
510(k)	K101772	TSRH(R) SPINAL SYSTEM	NKB	2010-09-30	View