FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Patriot SI Implant System
K Number: K250001
·
Decision Jun 3, 2025
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
14
Review Days
152
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Basic Information
- Device Name
- Patriot SI Implant System
- K Number
- K250001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Simplicity, LLC
- Date Received
- January 2, 2025
- Decision Date
- June 3, 2025
- 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 |
Similar 510(k) Clearances
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Other Clearances by Spinal Simplicity, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K231923 | Liberty SI Lateral Implant System | Dec 5, 2023 | Substantially Equivalent |
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| K221307 | Edge Upper Cervical System | Jul 10, 2023 | Substantially Equivalent |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Aug 19, 2022 | Substantially Equivalent |
| K211880 | Minuteman G5 MIS Fusion Plate | Mar 11, 2022 | Substantially Equivalent |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate | Dec 15, 2021 | Substantially Equivalent |