GUDID 00763000855109

INSTRUMENT 6248486 14X18X16 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00763000855109
NIH Device Record Key536bb576-ef58-4d84-aa67-570c023c984f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6248486
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
GS100763000855109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

Moist Heat or Steam Sterilization


[00763000855109]

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.

00199150023035 - Medtronic Reusable Instruments2025-09-09 INSERTER X1124001 TLIF RATCHETING
00199150023042 - Medtronic Reusable Instruments2025-09-09 INSERTER X1124002 RATCHETING KNOB
00763000874520 - SHILLA™ Growth Guidance System2025-09-09 SCREW 7673520 4.5 SHILLA FAS 5.5X20
00763000856663 - VERTE-STACK® Spinal System2025-09-08 IMPLANT 6240264 ANATOMIC 16X14X12MM
00763000856670 - VERTE-STACK® Spinal System2025-09-08 IMPLANT 6240364 ANATOMIC 16X14X13MM
00763000856687 - VERTE-STACK® Spinal System2025-09-08 IMPLANT 6240464 ANATOMIC 16X14X14MM
00763000856847 - VERTE-STACK® Spinal System2025-09-08 IMPLANT 6240541 ANATOMIC 14X11X5MM
00763000856892 - VERTE-STACK® Spinal System2025-09-08 IMPLANT 6240041 ANATOMIC 14X11X10MM

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