Anteralign Spinal System with Titan nanoLock Surface technology

GUDID 00763000147501

TRIAL 46821216 MD 12DG 32X25X16MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00763000147501
NIH Device Record Keye61bbe60-61cc-40b7-9d91-bd7bf1683fd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnteralign Spinal System with Titan nanoLock Surface technology
Version Model Number46821216
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
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
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
GS100763000147501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument
OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


[00763000147501]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [Anteralign Spinal System with Titan nanoLock Surface technology]

00763000198589TRIAL 46813420 24DG 23W 20X60MM
00763000198473TRIAL 46813614 6DG 23W 14X60MM
00763000193942INSERTER 4680005 INTERBODY/TRIAL SHAFT
00763000193935INSERTER 4680004 INTERBODY/TRIAL
00763000193881TRIAL 46813416 24DG 23W 16X60MM
00763000193874TRIAL 46813414 24DG 23W 14X60MM
00763000193867TRIAL 46813816 18DG 23W 16X60MM
00763000193850TRIAL 46813814 18DG 23W 14X60MM
00763000193843TRIAL 46813812 18DG 23W 12X60MM
00763000193836TRIAL 46813214 12DG 23W 14X60MM
00763000193829TRIAL 46813212 12DG 23W 12X60MM
00763000193812TRIAL 46813210 12DG 23W 10X60MM
00763000193805TRIAL 46813612 6DG 23W 12X60MM
00763000193799TRIAL 46813610 6DG 23W 10X60MM
00763000193782TRIAL 46813608 6DG 23W 8X60MM
00763000193775TRIAL 46812214 12DG 20W 14X60MM
00763000193768TRIAL 46812212 12DG 20W 12X60MM
00763000193751TRIAL 46812210 12DG 20W 10X60MM
00763000193744TRIAL 46812614 6DG 20W 14X60MM
00763000193737TRIAL 46812612 6DG 20W 12X60MM
00763000193720TRIAL 46812610 6DG 20W 10X60MM
00763000193713TRIAL 46812608 6DG 20W 8X60MM
00763000194000BLOCK 4680011 LOADING BLOCK
00763000193997DRIVER 4680010 T20 LONG SCREWDRIVER
00763000193980DRIVER 4680009 T20 SCREWDRIVER
00763000193973DRIVER 4680008 T20 BALLJOINT DRIVER
00763000193966INSERTER 4680007 MINIPLATE SHAFT
00763000193959INSERTER 4680006 MINIPLATE INSERTER
00763000198572TRIAL 46813418 24DG 23W 18X60MM
00763000198565TRIAL 46812420 24DG 20W 20X60MM
00763000198558TRIAL 46812418 24DG 20W 18X60MM
00763000198541TRIAL 46812416 24DG 20W 16X60MM
00763000198534TRIAL 46812414 24DG 20W 14X60MM
00763000198527TRIAL 46813820 18DG 23W 20X60MM
00763000198510TRIAL 46813818 18DG 23W 18X60MM
00763000198503TRIAL 46813218 12DG 23W 18X60MM
00763000198497TRIAL 46813216 12DG 23W 16X60MM
00763000198480TRIAL 46813616 6DG 23W 16X60MM
00763000198466TRIAL 46812820 18DG 20W 20X60MM
00763000198459TRIAL 46812818 18DG 20W 18X60MM
00763000198442TRIAL 46812816 18DG 20W 16X60MM
00763000198435TRIAL 46812814 18DG 20W 14X60MM
00763000198428TRIAL 46812812 18DG 20W 12X60MM
00763000198411TRIAL 46812218 12DG 20W 18X60MM
00763000198404TRIAL 46812216 12DG 20W 16X60MM
00763000198398TRIAL 46812616 6DG 20W 16X60MM
00763000128326NANO SPACER 46381845 TI 18DG 23W 18X45MM
00763000128302NANO SPACER 46381660 TI 18DG 23W 16X60MM
00763000194024SLAPHAMMER 4680013 DUAL-ENDED SLAPHAMMER
00763000193928AWL 4680003 STRAIGHT AWL SHAFT

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