Navigated Anterolateral Disc Prep Instruments

GUDID 00763000200879

DISTRACTOR NAV4680018 NAV DISTRACTOR 4MM

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic surgical distractor, internal
Primary Device ID00763000200879
NIH Device Record Keyc88a0ab8-6b1d-4a43-b9b2-bb56f3b9bc57
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigated Anterolateral Disc Prep Instruments
Version Model NumberNAV4680018
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 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

Device Dimensions

Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000200879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000200879]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-20
Device Publish Date2020-02-12

On-Brand Devices [Navigated Anterolateral Disc Prep Instruments]

00763000252021TRAY 4680106 NAV ANT/LAT DISC PREP LOWER
00763000226275TRAY 4680104 NAV ANT/LAT DISC PREP UPPER
00763000209728SLAPHAMMER 4680014 DUAL-ENDED NAV
00763000200930COBB NAV4680024 NAV COBB 23MM
00763000200923COBB NAV4680023 NAV COBB 18MM
00763000200916COBB NAV4680022 NAV COBB 10MM
00763000200909DISTRACTOR NAV4680021 NAV OBL/ANGLE 4MM
00763000200893DISTRACTOR NAV4680020 NAV DISTRACTOR 8MM
00763000200886DISTRACTOR NAV4680019 NAV DISTRACTOR 6MM
00763000200879DISTRACTOR NAV4680018 NAV DISTRACTOR 4MM
00763000200862RASP NAV4680017 NAV DOUBLE SIDED RASP
00763000200848CURETTE NAV4680011 NAV 45 DEG PULL 5MM
00763000200831CURETTE NAV4680010 NAV 45 DEG PUSH 5MM
00763000200824CURETTE NAV4680009 NAV STRAIGHT CUP 5MM
00763000200817OSTEOTOME NAV4680008 NAV STRAIGHT
00763000200800COBB NAV4680007 NAV OBL/ANGLE COBB 20MM
00763000200794COBB NAV4680006 NAV COBB ELEVATOR 20MM
00763000200787COBB NAV4680005 NAV COBB 20MM
00763000200855CURETTE NAV4680016 NAV UTERINE 11MM

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