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 00763000857530 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-01-07
GUDID 00763000857493 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-01-07
GUDID 00763000857349 MEDTRONIC SOFAMOR DANEK, INC.	VERTE-STACK® Spinal System	2025-01-07
GUDID 00763000848538 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-01-06
GUDID 00763000780616 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON® Spinal System	2025-01-06
GUDID 00763000764845 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000764838 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000764821 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000764814 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000764807 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000764791 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-01-06
GUDID 00763000764784 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2025-01-06
GUDID 00763000764777 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000720087 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000720070 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000720063 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000712020 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2025-01-06
GUDID 00763000712013 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000712006 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000711993 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2025-01-06
GUDID 00763000661403 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661397 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661380 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661373 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661366 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661359 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661342 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661304 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661298 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000661281 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658496 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658489 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658472 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658465 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658458 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658441 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658434 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658427 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658410 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658403 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658397 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658380 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658373 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658366 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658359 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658342 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658335 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658328 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658311 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658304 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658298 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658281 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658274 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658267 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658250 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658243 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658236 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658229 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658212 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658205 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658199 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658182 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658175 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658168 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658151 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658144 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658137 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658120 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658113 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658106 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000658090 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650537 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650520 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650513 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650506 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650490 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650483 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650476 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650469 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650452 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650445 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650438 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650421 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650414 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650407 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650391 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650384 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650377 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650360 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650353 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650346 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650339 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650322 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650315 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650308 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650292 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650285 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650278 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650261 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
GUDID 00763000650254 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ FNS Screw Set	2025-01-06
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