FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Minuteman® G6 MIS Fusion Plate
K Number: K253250
·
Decision Dec 1, 2025
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
14
Review Days
63
Basic Information
- Device Name
- Minuteman® G6 MIS Fusion Plate
- K Number
- K253250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Simplicity, LLC
- Date Received
- September 29, 2025
- Decision Date
- December 1, 2025
- Product Code
- PEK
- 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 |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Spinal Simplicity, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K250001 | Patriot SI Implant System | Jun 3, 2025 | Substantially Equivalent |
| K240592 | Wolff's Law Anterior Cervical Plate System | May 24, 2024 | Substantially Equivalent |
| K232259 | Patriot-SI Posterior Implant System | Apr 19, 2024 | Substantially Equivalent |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Jan 18, 2024 | Substantially Equivalent |
| K231923 | Liberty SI Lateral Implant System | Dec 5, 2023 | Substantially Equivalent |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Nov 29, 2023 | Substantially Equivalent |
| 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 |