KYPHON Xpander™ Inflatable Bone Tamp

GUDID 00613994703989

TAMP K13A XPAN INFLAT BONE SIZE 10/3-RB

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00613994703989
• NIH Device Record Key: 647f2367-9776-4ac9-a16d-4fef81d64ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Xpander™ Inflatable Bone Tamp
• Version Model Number: K13A
• 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: false
• 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	00613994703989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041454

FDA Product Code

• HRX: ARTHROSCOPE

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: 2016-07-16

On-Brand Devices [KYPHON Xpander™ Inflatable Bone Tamp]

• 00613994704009: TAMP K08A XPAN INFLAT BONE SIZE 20/3-RB
• 00613994703996: TAMP K09A XPAN INFLAT BONE SIZE 15/3-RB
• 00613994703989: TAMP K13A XPAN INFLAT BONE SIZE 10/3-RB
• 00643169103078: TAMP K13A XPAN INFLAT BONE SIZE 10/3
• 00643169103061: TAMP K09A XPAN INFLAT BONE SIZE 15/3
• 00643169103054: TAMP K08A XPAN INFLAT BONE SIZE 20/3
• 00858196001178: TAMP K13A XPANDR INFLAT BONE SIZE 10/3
• 00858196001161: TAMP K09A XPANDR INFLAT BONE SIZE 15/3
• 00858196001154: TAMP K08A XPANDR INFLAT BONE SIZE 20/3