Minuteman® G6 MIS Fusion Plate— 510(k) K253250

Name: FDA 510(k) clearance K253250
Creator: U.S. Food and Drug Administration
Published: 2025-12-01

Substantially Equivalent

Spinal Simplicity, LLC

FDA 510(k) clearance K253250 for Minuteman® G6 MIS Fusion Plate, Substantially Equivalent on 2025-12-01. Applicant: Spinal Simplicity, LLC. Device class: 2.

Clearance details

Applicant: Spinal Simplicity, LLC
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2025-09-29
Decision date: 2025-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEK

view all

K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18
K233527 — Minuteman G5 MIS Fusion Plate +3 more2023-11-29
K232484 — KeyLift Expandable Interlaminar Stabilization System2023-10-19
K231807 — primaLOK SP Interspinous Fusion System2023-08-15
K223790 — Huvex Interspinous Fusion System2023-03-09

More clearances from Spinal Simplicity, LLC

view all

K250001 — Patriot SI Implant System2025-06-03
K240592 — Wolff's Law Anterior Cervical Plate System2024-05-24
K232259 — Patriot-SI Posterior Implant System2024-04-19
K231923 — Liberty SI Lateral Implant System2023-12-05
K221307 — Edge Upper Cervical System2023-07-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.