FDA 510(k)

OsteoCoil™ Nitinol Compression System (Multiple Component PNs)

Номер K: K233567 · 2024-11-22

ЗаявительFlower Orthopedics Corporation Dba Conventus Flower Ortho

Дата решения2024-11-22

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K233567. 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™ Nitinol Compression System (Multiple Component PNs)?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. The 510(k) number is K233567.

When did OsteoCoil™ Nitinol Compression System (Multiple Component PNs) receive FDA 510(k) clearance?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) received FDA 510(k) clearance on 2024-11-22, under 510(k) number K233567.

Who is the listed applicant for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

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

What is the FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs) 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.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Официальный источник

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