FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iFuse INTRA Ti Implant System
K Number: K253488
·
Decision Feb 11, 2026
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
32
Review Days
110
Basic Information
- Device Name
- iFuse INTRA Ti Implant System
- K Number
- K253488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SI-BONE, Inc.
- Date Received
- October 24, 2025
- Decision Date
- February 11, 2026
- Product Code
- OUR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
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Other Clearances by SI-BONE, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253094 | iFuse Bedrock Granite Implant System | Oct 9, 2025 | Substantially Equivalent |
| K251780 | iGPS Navigation Instruments | Sep 15, 2025 | Substantially Equivalent |
| K241504 | iFuse TORQ TNT Implant System | Aug 19, 2024 | Substantially Equivalent |
| K241574 | iFuse TORQ® Implant System | Jul 2, 2024 | Substantially Equivalent |
| K232800 | Navigation Tracking Instruments | Feb 23, 2024 | Substantially Equivalent |
| K233508 | iFuse Bedrock Granite® Implant System | Jan 26, 2024 | Substantially Equivalent |
| K231689 | iFuse TORQ® Implant System | Jun 30, 2023 | Substantially Equivalent |
| K222774 | iFuse Bedrock Granite® Implant System | Dec 22, 2022 | Substantially Equivalent |
| K222605 | iFuse TORQ® Implant System | Sep 29, 2022 | Substantially Equivalent |
| K213667 | iFuse-TORQ® Implant System | Jun 10, 2022 | Substantially Equivalent |