Crescent Spinal System

GUDID 00643169665965

INSERTER X0515028 15 DEGREE ANGLED

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00643169665965
• NIH Device Record Key: 50d74b14-6bc1-4d2a-b3ab-ce2132f2b7ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crescent Spinal System
• Version Model Number: X0515028
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169665965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052261

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

[00643169665965]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-11-05

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00199150045471 - Medtronic Reusable Instruments: 2025-12-08 DRIVER X0419060 M25 ARTICULATING
• 00199150054039 - Medtronic Reusable Instruments: 2025-12-08 DRIVER EX0925005 SMALL SHANK
• 00199150054046 - Medtronic Reusable Instruments: 2025-12-08 DRIVER SLEEVE EX0925006 SMALL SHANK
• 00199150054053 - Medtronic Reusable Instruments: 2025-12-08 DRIVER EX0925007 SMALL SHANK LOCKING
• 00199150054688 - Medtronic Reusable Instruments: 2025-12-08 TLIF TULIP DISTRACTOR SCISSOR
• 00763000787660 - TSRH® Spinal System: 2025-12-05 ROD 8370040 TSR2D PCUT BENT 40MMX5.5MM
• 00199150044375 - Medtronic Reusable Instruments: 2025-12-02 CORONAL BENDER FULCRUM LEFT
• 00199150044382 - Medtronic Reusable Instruments: 2025-12-02 CORONAL BENDER FULCRUM RIGHT