FDA 510(k)

OsteoCoil™ GT Active Compression System

Номер K: K260106 · 2026-08-24

ЗаявительFlower Orthopedics Corporation DBA Conventus Flower Orthoped

Дата решения2026-08-24

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

OsteoCoil™ GT Active Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation DBA Conventus Flower Orthoped. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K260106. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OsteoCoil™ GT Active Compression System?

OsteoCoil™ GT Active Compression System is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is Flower Orthopedics Corporation DBA Conventus Flower Orthoped. The 510(k) number is K260106.

When did OsteoCoil™ GT Active Compression System receive FDA 510(k) clearance?

OsteoCoil™ GT Active Compression System received FDA 510(k) clearance on 2026-08-24, under 510(k) number K260106.

Who is the listed applicant for OsteoCoil™ GT Active Compression System?

The FDA 510(k) record lists Flower Orthopedics Corporation DBA Conventus Flower Orthoped as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCoil™ GT Active Compression System?

The FDA product code for OsteoCoil™ GT Active Compression System is HWC. This falls under the Cardiovascular category.

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: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.

Официальный источник

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