FDA 510(k)

Système de plating de la jambe inférieure AOS Fibonacci – Système de plating tibiale proximale AOS Proximal

Numéro K : K202489 · 2020-10-26

DemandeurAdvanced Orthopaedic Solutions, Inc.

Date de décision2020-10-26

Code produitHRS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2020-10-26 under 510(k) number K202489. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System?

AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K202489.

When did AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System receive FDA 510(k) clearance?

AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System received FDA 510(k) clearance on 2020-10-26, under 510(k) number K202489.

Who is the listed applicant for AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System?

The FDA product code for AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System is HRS.

Essais cliniques associés

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Dispositifs connexes (Code : HRS)

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Source officielle

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