KYPHON® ELEMENT™

GUDID 00763000025823

INFLATABLE BONE TAMP KR153 15MM VALUEIBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00763000025823
• NIH Device Record Key: b9251d77-c970-4237-9591-966610889f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® ELEMENT™
• Version Model Number: KR153
• 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
• 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 Dimensions

• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000025823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151532

FDA Product Code

• HXG: TAMP

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: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [KYPHON® ELEMENT™]

• 00643169582217: INFLATABLE BONE TAMP KR153 15MM VALUEIBT
• 00763000025823: INFLATABLE BONE TAMP KR153 15MM VALUEIBT