GUDID 00763000855093

INSTRUMENT 6248464 14X16X14 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00763000855093
NIH Device Record Keydbe8ff42-3187-41dd-be8e-c5a2812548bb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6248464
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
GS100763000855093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

Moist Heat or Steam Sterilization


[00763000855093]

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.

00763000665173 - ZEVO™ Anterior Cervical Plate System2025-03-05 SCREW G7713515 ZEVO VAR SD 3.5MM X 15MM
00643169468771 - CD HORIZON® Spinal System2025-03-03 DRIVER X1013216 STEP 5.5/6.0 RMAS SOLID
00763000855024 - n/a2025-02-28 INSTRUMENT 6248241 12X14X11 TRIAL
00763000857189 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277541 CORNERSTONE PSR 5X14X11MM
00763000857196 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277641 CORNERSTONE PSR 6X14X11MM
00763000857202 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277741 CORNERSTONE PSR 7X14X11MM
00763000857219 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277841 CORNERSTONE PSR 8X14X11MM
00763000857226 - VERTE-STACK® Spinal System2025-02-21 SPACER 6277941 CORNERSTONE PSR 9X14X11MM

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