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FDA 510(k)

Minuteman® G6 MIS Fusion Plate

K-Number: K253250 · 2025-12-01

ApplicantSpinal Simplicity, LLC
Decision Date2025-12-01
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Minuteman® G6 MIS Fusion Plate is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2025-12-01 under approval number K253250. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Minuteman® G6 MIS Fusion Plate?

Minuteman® G6 MIS Fusion Plate is a medical device that received FDA 510(k) clearance on 2025-12-01. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K253250.

When was Minuteman® G6 MIS Fusion Plate approved by the FDA?

Minuteman® G6 MIS Fusion Plate received FDA 510(k) clearance on 2025-12-01, under approval number K253250.

What company makes Minuteman® G6 MIS Fusion Plate?

Minuteman® G6 MIS Fusion Plate is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Minuteman® G6 MIS Fusion Plate?

The FDA product code for Minuteman® G6 MIS Fusion Plate is PEK.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Spinal Simplicity, LLC

K200066Posterior Fusion Plate, HA Posterior Fusion Plate K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 K211880Minuteman G5 MIS Fusion Plate K231923Liberty SI Lateral Implant System K233527Minuteman 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

View all 12 devices →

Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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