Titan Inserter

GUDID 00763000402594

INSERTER X0420002 ENDO TO INSERTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00763000402594
NIH Device Record Key41451e28-e776-4264-9e80-94ad117db172
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan Inserter
Version Model NumberX0420002
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000402594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWRDRIVER, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


[00763000402594]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-06
Device Publish Date2020-10-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000679422 - n/a2025-09-01 DRIVER 9870012 SCREW 3.2MM STRAIGHT HEX
00763000856717 - VERTE-STACK® Spinal System2025-09-01 IMPLANT 6240586 ANATOMIC 18X16X5MM
00763000856724 - VERTE-STACK® Spinal System2025-09-01 IMPLANT 6240686 ANATOMIC 18X16X6MM
00763000856885 - VERTE-STACK® Spinal System2025-09-01 IMPLANT 6240941 ANATOMIC 14X11X9MM
00763000856915 - VERTE-STACK® Spinal System2025-09-01 IMPLANT 6240241 ANATOMIC 14X11X12MM
00763000857004 - VERTE-STACK® Spinal System2025-09-01 STRUT 6242041 ANATOMIC 14X11X24MM
00763000664138 - ZEVO™ Anterior Cervical Plate System2025-08-29 PLATE G3005100 ZEVO 100MM 5 LVL
00199150021598 - Medtronic Reusable Instruments2025-08-26 DISTRACTOR X0425009 FRW FACING DUMBBELL

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.