FDA 510(k)

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

N.º K: K231272 · 2023-12-01

Fecha de decisión2023-12-01

Código de productoHTY

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231272. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is OSSIO , Ltd.. The 510(k) number is K231272.

When did OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail receive FDA 510(k) clearance?

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231272.

Who is the listed applicant for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

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

What is the FDA product code for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

The FDA product code for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is HTY.

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Otros registros que enlistan a OSSIO , Ltd. como solicitante

K254077OSSIOfiber® Threaded Trimmable Fixation Nail K254055OSSIOfiber® Suture Anchor K252022OSSIOfiber® Interference Screw K251309OSSIOfiber® Suture Anchor K243760OSSIOfiber® Suture Anchor 2.5-3.5 mm K241932OSSIOfiber® Compression Staple

Ver todos los 20 dispositivos →

Dispositivos relacionados (Código: HTY)

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

Fuente oficial

Ver en la base de datos de la FDA →

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