FDA 510(k)

Biolign® Roto-Loc Cervical Plate System

Número K: K200523 · 2020-04-30

RequerenteElite Surgical Supplies (Pty), Ltd.

Data da decisão2020-04-30

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biolign® Roto-Loc Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200523. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biolign® Roto-Loc Cervical Plate System?

Biolign® Roto-Loc Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K200523.

When did Biolign® Roto-Loc Cervical Plate System receive FDA 510(k) clearance?

Biolign® Roto-Loc Cervical Plate System received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200523.

Who is the listed applicant for Biolign® Roto-Loc Cervical Plate System?

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

What is the FDA product code for Biolign® Roto-Loc Cervical Plate System?

The FDA product code for Biolign® Roto-Loc Cervical Plate System is KWQ.

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