FDA 510(k)

Orthopaedic Surgery Planning Software (AIJOINT)

Número K: K233761 · 2024-08-05

RequerenteLongwood Valley Medical , Ltd.

Data da decisão2024-08-05

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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