FDA 510(k)

Orthopaedic Surgery Planning Software (AIJOINT)

Номер K: K233761 · 2024-08-05

Дата решения2024-08-05

Код продуктаLLZ

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Orthopaedic Surgery Planning Software (AIJOINT) is the device name listed in this FDA 510(k) record. The listed applicant is Longwood Valley Medical , Ltd.. It received FDA 510(k) clearance on 2024-08-05 under 510(k) number K233761. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Orthopaedic Surgery Planning Software (AIJOINT)?

Orthopaedic Surgery Planning Software (AIJOINT) is a medical device that received FDA 510(k) clearance on 2024-08-05. The listed applicant is Longwood Valley Medical , Ltd.. The 510(k) number is K233761.

When did Orthopaedic Surgery Planning Software (AIJOINT) receive FDA 510(k) clearance?

Orthopaedic Surgery Planning Software (AIJOINT) received FDA 510(k) clearance on 2024-08-05, under 510(k) number K233761.

Who is the listed applicant for Orthopaedic Surgery Planning Software (AIJOINT)?

The FDA 510(k) record lists Longwood Valley Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthopaedic Surgery Planning Software (AIJOINT)?

The FDA product code for Orthopaedic Surgery Planning Software (AIJOINT) is LLZ.

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: LLZ)

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Официальный источник

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