FDA 510(k)

Inspan ScrewLES Fusion System

Номер K: K213266 · 2021-12-03

Дата решения2021-12-03

Код продуктаPEK

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Inspan ScrewLES Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Lespine Innovations, LLC. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213266. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Inspan ScrewLES Fusion System?

Inspan ScrewLES Fusion System is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Lespine Innovations, LLC. The 510(k) number is K213266.

When did Inspan ScrewLES Fusion System receive FDA 510(k) clearance?

Inspan ScrewLES Fusion System received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213266.

Who is the listed applicant for Inspan ScrewLES Fusion System?

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

What is the FDA product code for Inspan ScrewLES Fusion System?

The FDA product code for Inspan ScrewLES Fusion System is PEK.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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