FDA 510(k)

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Número K: K240175 · 2024-10-29

Data da decisão2024-10-29

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K240175. 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.

Perguntas frequentes

What is the Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Tigon Medical. The 510(k) number is K240175.

When did Tigon Medical Fractures, Instability, and Reconstruction (FIRE) receive FDA 510(k) clearance?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K240175.

Who is the listed applicant for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

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

What is the FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

The FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is HWC. This falls under the Cardiovascular category.

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Outros registros que listam Tigon Medical como candidato(a)

K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K242529Tigon Medical All-Suture Anchors (ASA)K220464Tigon Medical Gryphon Anchor Line K211049Tigon Medical Button System K182507Tigon Medical Tissue Anchors

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Fonte oficial

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