FDA 510(k)

Orbitum Bone Staple Implant, X and VI

N.º K: K173693 · 2018-02-23

Fecha de decisión2018-02-23

Código de productoJDR

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Orbitum Bone Staple Implant, X and VI is the device name listed in this FDA 510(k) record. The listed applicant is Orthovestments, LLC. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173693. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Orbitum Bone Staple Implant, X and VI?

Orbitum Bone Staple Implant, X and VI is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Orthovestments, LLC. The 510(k) number is K173693.

When did Orbitum Bone Staple Implant, X and VI receive FDA 510(k) clearance?

Orbitum Bone Staple Implant, X and VI received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173693.

Who is the listed applicant for Orbitum Bone Staple Implant, X and VI?

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

What is the FDA product code for Orbitum Bone Staple Implant, X and VI?

The FDA product code for Orbitum Bone Staple Implant, X and VI is JDR.

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Fuente oficial

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