GUDID 00763000855116

INSTRUMENT 6248541 5X14X11 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00763000855116
NIH Device Record Keybc252da5-db4f-4d21-8323-0cdfa9b9d0aa
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6248541
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000855116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


[00763000855116]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00885074240695 - n/a2025-09-30 ACCESSORIES 3299003 GRAFT TAMP
00199150026029 - Medtronic Reusable Instruments2025-09-29 COMPRESSOR X0525001 RACK AND PINION
00763000684044 - Medtronic Reusable Instruments2025-09-29 INSTRUMENT 950-146 RULER
00763000856700 - VERTE-STACK® Spinal System2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM
00763000879563 - ENDOSKELETON® TCS2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE
00763000879587 - ENDOSKELETON® TCS2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT
00763000879600 - ENDOSKELETON® TCS2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT
00763000879648 - Endoskeleton™ TCS Interbody System2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM

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