FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iFuse Implant System - iFuse Navigation
K Number: K203110
·
Decision Nov 9, 2020
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
12
Review Days
25
Basic Information
- Device Name
- iFuse Implant System - iFuse Navigation
- K Number
- K203110
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SI-BONE, Inc.
- Date Received
- October 15, 2020
- Decision Date
- November 9, 2020
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by SI-BONE, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232800 | Navigation Tracking Instruments | Feb 23, 2024 | 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 |
| K220195 | iFuse Bedrock Granite Implant System | May 26, 2022 | Substantially Equivalent |
| K203247 | iFuse-TORQ Implant System | Feb 25, 2021 | Substantially Equivalent |
| K190230 | iFuse Implant System® | Apr 3, 2019 | Substantially Equivalent |
| K182983 | iFuse Implant System® | Nov 27, 2018 | Substantially Equivalent |
| K172268 | iFuse Implant System- iFuse Navigation | Oct 31, 2017 | Substantially Equivalent |
| K150875 | iFuse Implant System | Jul 22, 2015 | Substantially Equivalent |