Medtronic Sofamor Danek

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K212428 Medtronic Sofamor Danek	Centerpiece Plate Fixation System	2021-12-13
PMN K201267 Medtronic Sofamor Danek	Adaptix Interbody System With Titan NanoLOCK Surface Technology	2020-08-26
PMN K173125 Medtronic Sofamor Danek	T2 STRATOSPHERE™ Expandable Corpectomy System	2017-12-20
PMN K172328 Medtronic Sofamor Danek	SOVEREIGN™ Spinal System	2017-11-02
PMN K172199 Medtronic Sofamor Danek	ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium	2017-09-19
PMN K171031 Medtronic Sofamor Danek	CRESCENT™ Spinal System	2017-07-06
PMN K171468 Medtronic Sofamor Danek	FUSE Spinal System	2017-06-13
PMN K170679 Medtronic Sofamor Danek	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	2017-05-11
PMN K161210 Medtronic Sofamor Danek	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	2016-08-12
PMN K153373 Medtronic Sofamor Danek	CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device	2016-01-19

Similar & Related FDA Registered Companies

• MEDTRONIC SOFAMOR DANEK USA, INC
• Medtronic Sofamor Danek USA
• MEDTRONIC SOFAMOR DANEK, INC.
• Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000058 Supplement NumberS087 Date Received07/21/2022 Decision Date08/09/2022 Product Code NEK  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000054 Supplement NumberS068 Date Received07/21/2022 Decision Date08/09/2022 Product Code MPW  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000054 Supplement NumberS067 Date Received05/10/2022 Decision Date06/09/2022 Product Code MPW  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000058 Supplement NumberS086 Date Received05/10/2022 Decision Date06/08/2022 Product Code NEK  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No