FDA 510(k)

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

N.º K: K203465 · 2021-01-06

Fecha de decisión2021-01-06

Código de productoHTY

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K203465. 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 Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is OSSIO , Ltd.. The 510(k) number is K203465.

When did OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design receive FDA 510(k) clearance?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design received FDA 510(k) clearance on 2021-01-06, under 510(k) number K203465.

Who is the listed applicant for OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

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 Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

The FDA product code for OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design 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

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Dispositivos relacionados (Código: HTY)

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Fuente oficial

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