FDA 510(k)

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Número K: K260921 · 2026-04-21

Data da decisão2026-04-21

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K260921. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is Tigon Medical. The 510(k) number is K260921.

When did Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line receive FDA 510(k) clearance?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line received FDA 510(k) clearance on 2026-04-21, under 510(k) number K260921.

Who is the listed applicant for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

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 Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

The FDA product code for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is MBI.

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Outros registros que listam Tigon Medical como candidato(a)

K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K242529Tigon Medical All-Suture Anchors (ASA)K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)K220464Tigon Medical Gryphon Anchor Line K211049Tigon Medical Button System K182507Tigon Medical Tissue Anchors

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Fonte oficial

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