iFuse Navigation Tracking System

GUDID 00855369008927

FIXED TRACKER SCREWDRIVER

Si-Bone Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00855369008927
• NIH Device Record Key: 7511eea6-84ac-405b-aaa8-86616ae25c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse Navigation Tracking System
• Version Model Number: 400380
• Company DUNS: 830127168
• Company Name: Si-Bone 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: 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: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855369008927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232800

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

[00855369008927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [iFuse Navigation Tracking System]

• 00855369008934: Universal Pin Guide
• 00855369008927: FIXED TRACKER SCREWDRIVER
• 00855369008910: ROTATING TRACKER SET
• 00855369008903: FIXED TRACKER SET
• 00855369008897: ROTATING TRACKER - GREY
• 00855369008880: ROTATING TRACKER - GREEN
• 00855369008873: ROTATING TRACKER - ORANGE
• 00855369008866: ROTATING TRACKER - VIOLET
• 00855369008811: FIXED TRACKER - PURPLE
• 00855369008804: FIXED TRACKER - GREEN
• 00855369008798: FIXED TRACKER - GOLD
• 00855369008781: FIXED TRACKER - BLUE