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.

00199150002108 - Medtronic Reusable Instruments2025-06-09 SCREWDRIVER X2150100 MT25
00199150002115 - Medtronic Reusable Instruments2025-06-09 RETENTIVE X2151160 SLEEVE
00763000829933 - N/a2025-06-09 TRAY 5597907 SAS SV CEMENT DELIV DRIVER
00763000883461 - N/a2025-06-09 LOCK SLEEVE 7480756T LOCK SLEEVE
00763000883478 - N/a2025-06-09 SHAFT 7480757T MAS CEMENT DELIVERY
00763000883485 - N/a2025-06-09 SHAFT 7480758T SAS CEMENT DELIVERY
00763000884529 - N/A2025-06-09 TAP 7080920 4.0 X 13MM TAP
00763000889012 - ATLANTIS® Anterior Cervical Plate System2025-06-09 SCREW 3125413 4.5 X 13 SELF DRILL FIX

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