Navigated Anterolateral Disc Prep Instruments

GUDID 00763000200787

COBB NAV4680005 NAV COBB 20MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone lever/elevator

• Primary Device ID: 00763000200787
• NIH Device Record Key: 7b9cabcd-bb80-474c-b945-6e46b344953b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Anterolateral Disc Prep Instruments
• Version Model Number: NAV4680005
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000200787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192336

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

[00763000200787]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-20
• Device Publish Date: 2020-02-12

On-Brand Devices [Navigated Anterolateral Disc Prep Instruments]

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