iFuse TORQ Implant System-12.75 mm Awl Tip Tap

GUDID 00855369008385

12.75 mm Awl Tip Tap

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00855369008385
• NIH Device Record Key: 482dc954-21a7-4125-88d5-8f4d5fe00101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse TORQ Implant System-12.75 mm Awl Tip Tap
• Version Model Number: 501126-1275
• 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	00855369008385 [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

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

Moist Heat or Steam Sterilization

[00855369008385]

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

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• 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