FDA 510(k)

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

Número K: K242494 · 2024-11-26

Data da decisão2024-11-26

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242494. 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 OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K242494.

When did OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct receive FDA 510(k) clearance?

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242494.

Who is the listed applicant for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

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

What is the FDA product code for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

The FDA product code for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is MBI.

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Outros registros que listam Riverpoint Medical, LLC como candidato(a)

K253693Strut Suture; No-Tie Button K253695LigaMend K243988RootMend MRR K232411JuggerKnot Soft Anchor OC K231078All-Suture Anchor K231278Knotless Suture Anchor

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Dispositivos Relacionados (Código: MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Fonte oficial

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