TORQ TNT Dilator

GUDID 00810055523597

TORQ TNT Dilator

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00810055523597
• NIH Device Record Key: 59e5cd44-c795-4301-9b91-cbfc14c18a01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORQ TNT Dilator
• Version Model Number: 501767
• 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: true
• 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	00810055523597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241504

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

[00810055523597]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-25
• Device Publish Date: 2024-09-17

Devices Manufactured by Si-Bone Inc.

• 00869397000013 - XL Instrument Set: 2026-04-01 XL Instrument Set
• 00869397000020 - Radiolucent Instrument Set: 2026-04-01 Radiolucent Instrument Set
• 00869397000037 - Standard Instrument Set: 2026-04-01 Standard Instrument Set
• 00869397000044 - Removal System Instrument Set: 2026-04-01 Removal System Instrument Set
• 00869397000051 - 7.5mm & 10.75mm Instrument Set: 2026-04-01 7.5mm & 10.75mm Instrument Set
• 00810055525768 - iFuse INTRA Ti Implant: 2026-02-25 iFuse INTRA Ti Implant
• 00810055524754 - iGPS 4.3mm Drill Bit: 2025-10-01 iGPS 4.3mm Drill Bit
• 00810055524761 - iGPS 7.0mm Drill Bit: 2025-10-01 iGPS 7.0mm Drill Bit