KYPHON Xpander II KyphoPak Tray

GUDID 00763000026981

BONE TAMP KIT KPX103NB AF X2 10/3

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00763000026981
• NIH Device Record Key: 45b63a26-8293-4bdf-b0a9-e1cd75f98757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Xpander II KyphoPak Tray
• Version Model Number: KPX103NB
• 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
• 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
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000026981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101864

FDA Product Code

• HXG: TAMP

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-01-26

On-Brand Devices [KYPHON Xpander II KyphoPak Tray]

• 00763000031626: BONE TAMP KIT KPX203RB FF X2 20/3 OIS
• 00763000031602: BONE TAMP KIT KPX203PB FF X2 20/3 1 STP
• 00763000031589: BONE TAMP KIT KPX153RB FF X2 15/3 OIS
• 00763000031565: BONE TAMP KIT KPX153PB FF X2 15/3 1 STP
• 00763000031558: BONE TAMP KIT KPX103RB FF X2 10/3 OIS
• 00763000031541: BONE TAMP KIT KPX103PB FF X2 10/3 1 STP
• 00763000027032: BONE TAMP KIT KPX203NB AF X2 20/3
• 00763000027025: BONE TAMP KIT KPX203AB FF X2 20/3 AOIS
• 00763000027018: BONE TAMP KIT KPX153NB AF X2 15/3
• 00763000026998: BONE TAMP KIT KPX153AB FF X2 15/3 AOIS
• 00763000026981: BONE TAMP KIT KPX103NB AF X2 10/3
• 00763000026974: BONE TAMP KIT KPX103AB FF X2 10/3 AOIS