iFuse TORQ Implant System-iFuse-TORQ Instrument Set

GUDID 00810055520008

iFuse-TORQ Instrument Set

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00810055520008
• NIH Device Record Key: d630a5a5-fd9c-4861-8a3f-727d10a2e2ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse TORQ Implant System-iFuse-TORQ Instrument Set
• Version Model Number: 400287
• Company DUNS: 830127168
• Company Name: Si-Bone Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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	00810055520008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203247

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

[00810055520008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-16
• Device Publish Date: 2021-03-08

Devices Manufactured by Si-Bone Inc.

• 00810055524709 - iFuse TORQ TNT Instrument Tray: 2024-10-03 iFuse TORQ TNT Instrument Tray
• 00810055524716 - iFuse TORQ TNT Navigation Instrument Tray: 2024-10-03 iFuse TORQ TNT Navigation Instrument Tray
• 00810055523498 - Trocar Pin, 2.0 mm x 250 mm, TORQ TNT: 2024-09-25 Trocar Pin, 2.0 mm x 250 mm, TORQ TNT
• 00810055523504 - Trocar Pin, 2.0 mm x 330 mm, TORQ TNT: 2024-09-25 Trocar Pin, 2.0 mm x 330 mm, TORQ TNT
• 00810055523511 - Trocar Pin, 2.5 mm x 330 mm: 2024-09-25 Trocar Pin, 2.5 mm x 330 mm
• 00810055523528 - Drill Pin, 2.5 mm x 330 mm: 2024-09-25 Drill Pin, 2.5 mm x 330 mm
• 00810055523535 - Reverse Threaded Pin, 2.5 mm x 330 mm: 2024-09-25 Reverse Threaded Pin, 2.5 mm x 330 mm
• 00810055523542 - Trocar Pin, 2.5 mm x 450 mm: 2024-09-25 Trocar Pin, 2.5 mm x 450 mm