FDA 510(k)

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

Número K: K201259 · 2021-01-08

Data da decisão2021-01-08

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K201259. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K201259.

When did ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System receive FDA 510(k) clearance?

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System received FDA 510(k) clearance on 2021-01-08, under 510(k) number K201259.

Who is the listed applicant for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

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

What is the FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

The FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is HRS.

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