TANGENT® Plus Reusable Instruments

GUDID 00613994115294

INSTRUMENT 9076240 THREADED INSERTER

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994115294
• NIH Device Record Key: 356a361e-ecb6-4925-8d59-516794608b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TANGENT® Plus Reusable Instruments
• Version Model Number: 9076240
• 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: 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994115294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040422

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

[00613994115294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-10

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000873622 - DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM: 2025-04-18 SCREW PK2 G7743515 MINIP S-T 3.5MM X15MM
• 00763000873639 - DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM: 2025-04-18 SCREW PK2 G7743513 MINIP S-T 3.5MM X13MM
• 00643169699885 - PIVOX™ Oblique Lateral Spinal System: 2025-04-14 TRAY 2201006 PIVOX PLATE INSTRUMENTS
• 00763000855741 - PYRAMESH® C Titanium Mesh: 2025-04-14 MESH 9051790 PYRM IMPL 17MMX22MMX90MM
• 00763000855888 - PYRAMESH® Implant System: 2025-04-14 MESH 9052830 PYRAMESH IMP 22MMX28MMX30MM
• 00763000964429 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593001 STERILE PEDICLE SM
• 00763000964436 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593002 STERILE PEDICLE MD
• 00763000964443 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593011 STERILE WIDE BLADE SM