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.

00763000839598 - Medtronic Reusable Instruments2025-09-23 BLADE X07310017 DILATOR 4 SLIM
00763000684068 - Medtronic Reusable Instruments2025-09-16 INSTRUMENT 9339010 MODULAR DRILL HANDLE
00763000684112 - N/A2025-09-16 INSTRUMENT 9339095 CALIPER
00763000884833 - N/A2025-09-16 INSTRUMENT 7081912 DTS GUIDE
00763000885076 - N/A2025-09-16 DRILL BIT 7080613 NON STERILE 13MM
00763000885274 - N/A2025-09-16 TRAIL 8740041 10X14X11 CORNERSTONE SR
00763000885281 - N/A2025-09-16 TRAIL 8740141 11X14X11 CORNERSTONE SR
00763000885298 - N/A2025-09-16 TRAIL 8740241 12X14X11 CORNERSTONE SR

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