FDA 510(k)

Minuteman® G6 MIS Fusion Plate

Número K: K253250 · 2025-12-01

Data da decisão2025-12-01

Código do produtoPEK

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K253250.

When did Minuteman® G6 MIS Fusion Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for Minuteman® G6 MIS Fusion Plate?

The FDA 510(k) record lists Spinal Simplicity, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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Outros registros que listam Spinal Simplicity, LLC como candidato(a)

K250001Patriot SI Implant System K240592Wolff's Law Anterior Cervical Plate System K232259Patriot-SI Posterior Implant System K234051Minuteman 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 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

Ver todos os 12 dispositivos →

Dispositivos Relacionados (Código: PEK)

K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLC 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 PlateSpinal Simplicity, LLC K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC

Fonte oficial

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