RIALTO™ SI FUSION SYSTEM

GUDID 00643169572546

DRIVER 7426000 RIALTO ADJUSTMENT

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant driver

• Primary Device ID: 00643169572546
• NIH Device Record Key: a7f095ee-5d11-4aa6-961a-4947c6450829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIALTO™ SI FUSION SYSTEM
• Version Model Number: 7426000
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169572546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161210

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

[00643169572546]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-08

On-Brand Devices [RIALTO™ SI FUSION SYSTEM]

• 00643169572577: TAP 7426003 RIALTO 12MM
• 00643169572560: REAMER 7426002 RIALTO 8.6MM
• 00643169571860: DEVICE 74200001260 THREADED 12X60
• 00643169571846: DEVICE 74200001250 THREADED 12X50
• 00643169571822: DEVICE 74200001240 THREADED 12X40
• 00643169571815: REAMER NAV7426002 PILOT RIALTO
• 00643169571808: DRIVER NAV7426001 SCREW RIALTO
• 00643169571792: TAP NAV7426000 SELF DRILLING RIALTO
• 00643169572546: DRIVER 7426000 RIALTO ADJUSTMENT
• 00643169273924: SCREW 9000240 SI TI CANN 12X40
• 00643169273900: SCREW 9000245 SI TI CANN 12X45
• 00643169273887: SCREW 9000250 SI TI CANN 12X50
• 00643169273863: SCREW 9000255 SI TI CANN 12X55
• 00643169273849: SCREW 9000260 SI TI CANN 12X60
• 00643169572584: DRIVER 7426004 RIALTO T27 THREADED