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FDA 510(k)

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

Número K: K230517 · 2023-09-11

RequerenteJarmon Medical, LLC (Dba Legends Orthopedics)
Data da decisão2023-09-11
Código do produtoMBI
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) is the device name listed in this FDA 510(k) record. The listed applicant is Jarmon Medical, LLC (Dba Legends Orthopedics). It received FDA 510(k) clearance on 2023-09-11 under 510(k) number K230517. 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 Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)?

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is Jarmon Medical, LLC (Dba Legends Orthopedics). The 510(k) number is K230517.

When did Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) receive FDA 510(k) clearance?

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) received FDA 510(k) clearance on 2023-09-11, under 510(k) number K230517.

Who is the listed applicant for Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)?

The FDA 510(k) record lists Jarmon Medical, LLC (Dba Legends Orthopedics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)?

The FDA product code for Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) is MBI.

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