KYPHON Xpander™ Inflatable Bone Tamp

GUDID 00858196001161

TAMP K09A XPANDR INFLAT BONE SIZE 15/3

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00858196001161
• NIH Device Record Key: 207df556-554b-44a2-90c1-5aab60c9083e
• Commercial Distribution Discontinuation: 2018-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KYPHON Xpander™ Inflatable Bone Tamp
• Version Model Number: K09A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858196001161 [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: 4
• Public Version Date: 2019-01-25
• 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