FDA 510(k)

Posterior Fusion Plate, HA Posterior Fusion Plate

Número K: K200066 · 2020-12-10

Data da decisão2020-12-10

Código do produtoPEK

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Posterior Fusion Plate, HA Posterior 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 2020-12-10 under 510(k) number K200066. 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 Posterior Fusion Plate, HA Posterior Fusion Plate?

Posterior Fusion Plate, HA Posterior Fusion Plate is a medical device that received FDA 510(k) clearance on 2020-12-10. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K200066.

When did Posterior Fusion Plate, HA Posterior Fusion Plate receive FDA 510(k) clearance?

Posterior Fusion Plate, HA Posterior Fusion Plate received FDA 510(k) clearance on 2020-12-10, under 510(k) number K200066.

Who is the listed applicant for Posterior Fusion Plate, HA Posterior 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 Posterior Fusion Plate, HA Posterior Fusion Plate?

The FDA product code for Posterior Fusion Plate, HA Posterior Fusion Plate is PEK.

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

K253250Minuteman® G6 MIS Fusion Plate 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

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Dispositivos Relacionados (Código: PEK)

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC 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.

Fonte oficial

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