KYPHON® Express™ II Inflatable Bone Tamp

GUDID 00763000312015

BONE TAMP KE102 10/2 EXPRESS II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00763000312015
• NIH Device Record Key: d1fea627-f431-44d4-84e9-765e611875d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Express™ II Inflatable Bone Tamp
• Version Model Number: KE102
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000312015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123771

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: 2020-10-05
• Device Publish Date: 2020-09-25

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00199150026029 - Medtronic Reusable Instruments: 2025-09-29 COMPRESSOR X0525001 RACK AND PINION
• 00763000684044 - Medtronic Reusable Instruments: 2025-09-29 INSTRUMENT 950-146 RULER
• 00763000856700 - VERTE-STACK® Spinal System: 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM
• 00763000879563 - ENDOSKELETON® TCS: 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE
• 00763000879587 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT
• 00763000879600 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT
• 00763000879648 - Endoskeleton™ TCS Interbody System: 2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM