Navigated INFINITY™ Occipitocervical Upper Thoracic System

GUDID 00643169799936

DRILL BIT NAVG3606010 NAVIGATED

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, single-use, sterile
Primary Device ID00643169799936
NIH Device Record Key43d1a206-110d-49a4-96d1-0f16a3e312be
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigated INFINITY™ Occipitocervical Upper Thoracic System
Version Model NumberNAVG3606010
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exempttrue
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
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
GS100643169799936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-22
Device Publish Date2018-07-30

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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