iFuse INTRA Ti Implant

GUDID 00810055525768

iFuse INTRA Ti Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00810055525768
• NIH Device Record Key: ff31878b-3b8f-47f9-acd9-be24ee124297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse INTRA Ti Implant
• Version Model Number: 6030K
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055525768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253488

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-25
• Device Publish Date: 2026-02-17

Devices Manufactured by Si-Bone Inc.

• 00810055525768 - iFuse INTRA Ti Implant: 2026-02-25iFuse INTRA Ti Implant
• 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
• 00810055524778 - iGPS 8.5mm Drill Bit: 2025-10-01 iGPS 8.5mm Drill Bit
• 00810055524785 - iGPS 10.5mm Drill Bit: 2025-10-01 iGPS 10.5mm Drill Bit
• 00810055524792 - Granite iGPS 8.5mm Awl Tip Tap: 2025-10-01 Granite iGPS 8.5mm Awl Tip Tap
• 00810055524808 - Granite iGPS 9.0mm Awl Tip Tap: 2025-10-01 Granite iGPS 9.0mm Awl Tip Tap
• 00810055524815 - Granite iGPS 9.5mm Awl Tip Tap: 2025-10-01 Granite iGPS 9.5mm Awl Tip Tap