Vantage Anterior Fixation System

GUDID 00613994839237

BOLT X0410360 VAN TI 9X30

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00613994839237
NIH Device Record Key9718b861-6a39-4c76-84df-5f81f273a78a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVantage Anterior Fixation System
Version Model NumberX0410360
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 Usetrue
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

Device Dimensions

Length30 Millimeter
Length30 Millimeter
Length30 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994839237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994839237]

Moist Heat or Steam Sterilization


[00613994839237]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-09

On-Brand Devices [Vantage Anterior Fixation System]

00613994839305BOLT X0410352 VAN TI 8X35
00613994839299BOLT X0410353 VAN TI 8X40
00613994839282BOLT X0410354 VAN TI 8X45
00613994839275BOLT X0410355 VAN TI 8X50
00613994839268BOLT X0410356 VAN TI 8X55
00613994839251BOLT X0410358 VAN TI 9X20
00613994839244BOLT X0410359 VAN TI 9X25
00613994839237BOLT X0410360 VAN TI 9X30
00613994839220BOLT X0410361 VAN TI 9X35
00613994839213BOLT X0410362 VAN TI 9X40
00613994839206BOLT X0410363 VAN TI 9X45
00613994839190BOLT X0410364 VAN TI 9X50
00613994839183BOLT X0410365 VAN TI 9X55

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