GUDID 00763000300227

TRACKER 9734734 NAVLOCK UNIVERSAL GREEN

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system
Primary Device ID00763000300227
NIH Device Record Keyc96fc942-1045-4ab4-8323-e0f2d8d35188
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9734734
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000300227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


[00763000300227]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-08

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00763000255565 - N/A2025-09-29 TRIAL 9734663 CLYDESDALE 14X50MM
00763000255589 - N/A2025-09-29 TRIAL 9734664 CLYDESDALE 14X55MM
00199150014699 - NavLock™2025-09-26 INST SET 9734492 SOLERA DEF UPGRADE
00199150014729 - SOLERA2025-09-26 INST SET 9735284 SOLERA NONCAN TAPS
00199150014736 - SOLERA2025-09-26 INST SET 9735285 SOLERA ILIAC TAPS A^
00763000244965 - N/A2025-09-26 SCREWDRIVER 9734274 LGY G4 STANDARD
00763000244972 - N/A2025-09-26 SCREWDRIVER 9734275 LGY G4 REDUCTION
00763000244989 - N/A2025-09-26 SCREWDRIVER 9734278 LGY G4 PEEK STANDARD

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.