DeviceClearance

Minuteman G6 MIS Fusion Plate +6 more— 510(k) K261607

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K261607 for Minuteman G6 MIS Fusion Plate +6 more, Substantially Equivalent on 2026-10-02. Applicant: Spinal Simplicity, LLC. Device class: 2.

Summary

Spinal Simplicity's clearance bundles several product lines: Minuteman fusion plates (G1, G3, G3-R, G5, and G6, some in HA versions), the Patriot SI Implant System, and the Liberty SI Lateral Implant System. Product code PEK is spinous process plates. The SI systems sit under the same code here, and the record doesn't explain how they fit it.

Class II, 21 CFR 888.3050. The Orthopedic panel reviewed it as a Traditional 510(k).

Spinal Simplicity filed from Overland Park, Kansas. Review took 141 days (May 14 to October 2, 2026).

Clearance details

Device name as filed
Minuteman G6 MIS Fusion Plate; 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; Patriot SI Implant System; Liberty SI Lateral Implant System
Applicant
Spinal Simplicity, LLC
Product code
Product code PEK
Device class
Class 2
Regulation
21 CFR 888.3050
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Overland Park, KS, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.