Kyphon VuE Bone Cement and Kyphon Mixer

GUDID 00763000590970

BONE CEMENT CT01B KYPHON VUE W MIXER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00763000590970
• NIH Device Record Key: 8f6206d2-3f5c-4c5d-9059-fd9107bdf8ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyphon VuE Bone Cement and Kyphon Mixer
• Version Model Number: CT01B
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000590970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220131

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-02
• Device Publish Date: 2022-07-25

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00681490520089 - n/a: 2024-12-30 INSTRUMENT 8756412 DISTRACTOR PIN 12MM
• 20763000710525 - CD Horizon™ ModuLeX™ Spinal System: 2024-12-23 DRMAS 559200101 HEAD W/2 SET SCREWS
• 20763000710532 - CD Horizon™ ModuLeX™ Spinal System: 2024-12-23 RDRMAS 559200102 HEAD W/2 SET SCREWS
• 00763000857172 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277441 CORNERSTONE PSR 4X14X11MM
• 00763000857387 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277006 PSR STRUT 6 X 14 X 11MM
• 00763000868475 - CORNERSTONE® PSR Cervical Fusion System: 2024-12-16 IMPLANT 6284641 PEEK CRV 14X11X6MM