FDA 510(k)

Крюк с волоконной проволокой и disposable inserter

Номер K: K253027 · 2026-05-06

ЗаявительOrtobio S.A.

Дата решения2026-05-06

Код продуктаMBI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Anchor with Fiber Wire and Disposable Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Ortobio S.A.. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K253027. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Anchor with Fiber Wire and Disposable Inserter?

Anchor with Fiber Wire and Disposable Inserter is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Ortobio S.A.. The 510(k) number is K253027.

When did Anchor with Fiber Wire and Disposable Inserter receive FDA 510(k) clearance?

Anchor with Fiber Wire and Disposable Inserter received FDA 510(k) clearance on 2026-05-06, under 510(k) number K253027.

Who is the listed applicant for Anchor with Fiber Wire and Disposable Inserter?

The FDA 510(k) record lists Ortobio S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anchor with Fiber Wire and Disposable Inserter?

The FDA product code for Anchor with Fiber Wire and Disposable Inserter is MBI.

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: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK набор для анкеров тениArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Официальный источник

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