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 00763000918057 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-16
GUDID 00763000918040 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-16
GUDID 00763000918033 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-16
GUDID 00763000916145 MEDTRONIC SOFAMOR DANEK, INC.	MSB Reusable Instruments	2024-04-08
GUDID 00763000897192 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897185 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897178 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897161 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897154 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897147 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897130 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897123 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897116 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897109 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897093 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897086 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897079 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897062 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897055 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897048 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897031 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000897024 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-04-02
GUDID 00763000764043 MEDTRONIC SOFAMOR DANEK, INC.	OsteoCool™ 2.0 RF Ablation System	2024-04-01
GUDID 00763000764029 MEDTRONIC SOFAMOR DANEK, INC.	OsteoCool™ 2.0 RF Ablation System	2024-04-01
GUDID 00763000764005 MEDTRONIC SOFAMOR DANEK, INC.	OsteoCool™ 2.0 RF Ablation System	2024-04-01
GUDID 00763000711771 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-04-01
GUDID 00763000311650 MEDTRONIC SOFAMOR DANEK, INC.	KYPHON® Bone Filler Device (BFD)	2024-03-29
GUDID 00763000835170 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-03-25
GUDID 00763000835156 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-03-25
GUDID 00763000835132 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-03-25
GUDID 00763000835118 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-03-25
GUDID 00763000835095 MEDTRONIC SOFAMOR DANEK, INC.	Medtronic Reusable Instruments	2024-03-25
GUDID 00763000585020 MEDTRONIC SOFAMOR DANEK, INC.	CD HORIZON® Spinal System	2024-03-25
GUDID 00763000516543 MEDTRONIC SOFAMOR DANEK, INC.	Anteralign Spinal System with Titan nanoLock Surface technology	2024-03-15
GUDID 00763000845025 MEDTRONIC SOFAMOR DANEK, INC.	General Instruments	2024-03-11
GUDID 00763000865610 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000865603 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000845001 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825973 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825966 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825959 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825935 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825874 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000825867 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-06
GUDID 00763000878665 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000878191 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878184 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878177 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878160 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878153 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878146 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878139 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878122 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000878115 MEDTRONIC SOFAMOR DANEK, INC.	DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM	2024-03-04
GUDID 00763000877941 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877927 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877880 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877873 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877866 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877859 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877842 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877835 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877828 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877811 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877804 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877798 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877781 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000877774 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000868161 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865115 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865108 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865092 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865085 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865078 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000865061 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864576 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864569 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864552 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864545 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864538 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864521 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864514 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864507 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864491 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864484 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864477 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864460 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864453 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864446 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864439 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864422 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864415 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864408 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864392 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864385 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864378 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000864361 MEDTRONIC SOFAMOR DANEK, INC.	N/A	2024-03-04
GUDID 00763000703028 MEDTRONIC SOFAMOR DANEK, INC.	CD Horizon™ ModuLeX™ Spinal System	2024-03-04
GUDID 00763000703004 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2024-03-04
GUDID 00763000702991 MEDTRONIC SOFAMOR DANEK, INC.	n/a	2024-03-04
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