Vertex Select

GUDID 00643169713352

BIT NAV2075K VRT STERILE DRILL BIT 2.4MM

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, single-use, sterile

• Primary Device ID: 00643169713352
• NIH Device Record Key: 4b6ff976-537e-4adb-8fdb-a716d7fc2276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex Select
• Version Model Number: NAV2075K
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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
• 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

• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169713352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143628

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-01-19

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00199150065356 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025036 SHAFT 5.5/6.0 RODS
• 00199150065363 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025037 CLAMP
• 00199150065370 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025038 HANDLE
• 00199150065387 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025039 LINK ROD
• 00763000856816 - VERTE-STACK® Spinal System: 2026-02-10 STRUT 6241086 ANATOMIC 18X16X5MM
• 00763000856823 - VERTE-STACK® Spinal System: 2026-02-10 STRUT 6242086 ANATOMIC 18X16X24MM
• 00763000856953 - VERTE-STACK® Spinal System: 2026-02-10 IMPLANT 6240964 ANATOMIC 16X14X9MM