SiLo™ Spinal System

GUDID 00885074275109

FAS FOR 5.5MM ROD, 5.5X25, TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00885074275109
• NIH Device Record Key: fa6e0f28-00e4-4d3a-937c-165bf314a18c
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SiLo™ Spinal System
• Version Model Number: 8892525
• 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: true
• 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 Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074275109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042210

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00885074275109]

Moist Heat or Steam Sterilization

[00885074275109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-30
• Device Publish Date: 2015-08-04

On-Brand Devices [SiLo™ Spinal System]

• 00885074275277: FAS FOR 5.5MM ROD, 6.5X60, TI
• 00885074275215: FAS FOR 5.5MM ROD, 6.5X30, TI
• 00885074275178: FAS FOR 5.5MM ROD, 5.5X55, TI
• 00885074275109: FAS FOR 5.5MM ROD, 5.5X25, TI
• 00885074274843: FAS FOR 5.5MM ROD, 5.0X30, TI