Medtronic HV-R® Fenestrated Screw Cement

GUDID 00643169715127

CEMENT 7480724T FENESTRATED SCRW PMMA US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated

• Primary Device ID: 00643169715127
• NIH Device Record Key: 2d2191c4-3d6f-43af-b16f-597d92e5f64a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic HV-R® Fenestrated Screw Cement
• Version Model Number: 7480724T
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169715127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152604

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-09

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000857523 - VERTE-STACK® Spinal System: 2025-01-28 SPACER 6287541 PSR LAT PORTS 5X14X11
• 00763000868482 - CORNERSTONE® PSR Cervical Fusion System: 2025-01-28 IMPLANT 6284541 PEEK CRV 14X11X5MM
• 00763000911010 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675120 BONE SCREW 20MM
• 00763000911027 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675125 BONE SCREW 25MM
• 00763000911034 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675130 BONE SCREW 30MM
• 00763000911041 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675135 BONE SCREW 35MM
• 00763000911058 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675140 BONE SCREW 40MM
• 00763000911065 - Anteralign Spinal System with Titan nanoLOCK Surface Technology: 2025-01-28 BONE SCREW 4675145 BONE SCREW 45MM