No

GUDID 00763000522896

ADAPTER 5599061 RETAINING BRKOFF DRIVER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool

• Primary Device ID: 00763000522896
• NIH Device Record Key: 9283feb0-08a3-49b7-9f5c-4d60dda82975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No
• Version Model Number: 5599061
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000522896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201407

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

[00763000522896]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-20
• Device Publish Date: 2021-09-11

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00643169281165 - CD HORIZON® ASTUTE™ SPINAL SYSTEM: 2024-05-27 PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM
• 00763000242503 - MSB Reusable Instruments: 2024-05-27 GRAFT DELIVERY 6061007 GUN HANDLE
• 00763000914103 - MSB Reusable Instruments: 2024-05-27 OSTEOTOME EX0823011 1/4 WIDE SHARP
• 00763000914110 - MSB Reusable Instruments: 2024-05-27 OSTEOTOME EX0823012 1/2 WIDE SHARP
• 00763000940454 - Medtronic Reusable Instruments: 2024-05-27 TRIAL X0420013 16DEG 16MM LARGE
• 00763000940607 - Medtronic Reusable Instruments: 2024-05-27 TRIAL X0420028 20DEG 14MM LARGE
• 00763000940614 - Medtronic Reusable Instruments: 2024-05-27 TRIAL X0420029 20DEG 16MM LARGE
• 00763000940621 - Medtronic Reusable Instruments: 2024-05-27 TRIAL X0420030 20DEG 18MM LARGE