Medtronic Sofamor Danek Inc

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek Inc. 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
GUDID 00763000878085 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON® Spinal System	2025-04-22
GUDID 00763000868499 MEDTRONIC SOFAMOR DANEK, INC.	CORNERSTONE® PSR Cervical Fusion System	2025-04-22
GUDID 00763000868451 MEDTRONIC SOFAMOR DANEK, INC.	CORNERSTONE® PSR Cervical Fusion System	2025-04-22
GUDID 00763000868444 MEDTRONIC SOFAMOR DANEK, INC.	CORNERSTONE® PSR Cervical Fusion System	2025-04-22
GUDID 00763000868437 MEDTRONIC SOFAMOR DANEK, INC.	CORNERSTONE® PSR Cervical Fusion System	2025-04-22
GUDID 00763000857653 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857639 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857622 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857615 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857608 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857592 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857585 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857578 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857486 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857479 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857462 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857455 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857448 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857424 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857417 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857370 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857363 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857325 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857318 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857301 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857295 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857271 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857264 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857257 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857240 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857233 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857165 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857158 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857141 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857127 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857110 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857103 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857097 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857080 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857073 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857066 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857059 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000857035 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-22
GUDID 00763000787820 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON® Spinal System	2025-04-22
GUDID 00763000888275 MEDTRONIC SOFAMOR DANEK, INC.	TSRH® Spinal System	2025-04-21
GUDID 00763000880712 MEDTRONIC SOFAMOR DANEK, INC.	MSD WIRE System	2025-04-21
GUDID 00763000880699 MEDTRONIC SOFAMOR DANEK, INC.	MSD WIRE System	2025-04-21
GUDID 00763000873646 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-21
GUDID 00763000873554 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-21
GUDID 00763000873547 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-21
GUDID 00763000873530 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-21
GUDID 00763000857356 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-21
GUDID 00763000857332 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-04-21
GUDID 00763000855833 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-21
GUDID 00763000855789 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-21
GUDID 00763000855420 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-21
GUDID 00763000855161 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-04-21
GUDID 00763000787868 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON® Spinal System	2025-04-21
GUDID 00763000663650 MEDTRONIC SOFAMOR DANEK, INC.	ZEVO™ Anterior Cervical Plate System	2025-04-21
GUDID 00763000663391 MEDTRONIC SOFAMOR DANEK, INC.	ZEVO™ Anterior Cervical Plate System	2025-04-21
GUDID 00643169571853 MEDTRONIC SOFAMOR DANEK, INC.	RIALTO™ SI FUSION SYSTEM	2025-04-21
GUDID 00763000873639 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-18
GUDID 00763000873622 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM	2025-04-18
GUDID 00763000964566 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964559 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964542 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964535 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964528 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964511 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964504 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964498 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964481 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964474 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964467 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964450 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964443 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964436 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000964429 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-14
GUDID 00763000855888 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-14
GUDID 00763000855741 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-14
GUDID 00643169699885 MEDTRONIC SOFAMOR DANEK, INC.	PIVOX™ Oblique Lateral Spinal System	2025-04-14
GUDID 00763000856496 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-11
GUDID 00763000855826 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-11
GUDID 00763000855802 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-11
GUDID 00763000855796 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® Implant System	2025-04-11
GUDID 00763000855727 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-11
GUDID 00763000855529 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-11
GUDID 00763000855406 MEDTRONIC SOFAMOR DANEK, INC.	PYRAMESH® C Titanium Mesh	2025-04-11
GUDID 00763000964733 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964726 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964719 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964702 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964696 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964689 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964672 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964665 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964658 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964641 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000964634 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-04-08
GUDID 00763000883492 MEDTRONIC SOFAMOR DANEK, INC.	IB3D™ PL Spinal System	2025-04-08
PMA P060018S005 MEDTRONIC SOFAMOR DANEK, INC.	PRESTIGE CERVICAL DISC SYSTEM	2016-08-11
PMA P060018S004 MEDTRONIC SOFAMOR DANEK, INC.	PRESTIGE® Cervical Disc	2016-07-20
PMA P040001S021 MEDTRONIC SOFAMOR DANEK, INC.	X-STOP LTOS	2014-12-12
PMA P040001S022 MEDTRONIC SOFAMOR DANEK, INC.	X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM	2014-10-24
PMN K141824 MEDTRONIC SOFAMOR DANEK, INC.	MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP	2014-09-05
PMN K140417 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM	2014-07-09
PMN K140449 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON SPINAL SYSTEM	2014-03-25
PMN K132897 MEDTRONIC SOFAMOR DANEK, INC.	CLYDESDALE SPINAL SYSTEM	2013-12-11
PMN K133216 MEDTRONIC SOFAMOR DANEK, INC.	CRESCENT SPINAL SYSTEM	2013-11-22
PMA P060018S003 MEDTRONIC SOFAMOR DANEK, INC.	PRESTIGE CERVICAL DISC	2013-07-12
PMA P040001S020 MEDTRONIC SOFAMOR DANEK, INC.	X-STOP INTERSPINOUS SPACER SYSTEM	2012-07-25

Similar & Related FDA Registered Companies

• MEDTRONIC SOFAMOR DANEK USA, 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