KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack

GUDID 00643169097797

BONE CEMENT CX01B XPEDE W MIXER US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated

• Primary Device ID: 00643169097797
• NIH Device Record Key: 0245ca85-ac27-4b04-9c0c-efa11689c55d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack
• Version Model Number: CX01B
• 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	00643169097797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102397

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

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: 2015-09-02

On-Brand Devices [KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack]

• 00613994831507: BONE CEMENT CX01B KYPHON XPEDE W MXR US
• 00643169097797: BONE CEMENT CX01B XPEDE W MIXER US