FDA 510(k)

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System

Número K: K180980 · 2018-10-27

RequerenteCamber Spine Technologies, LLC

Data da decisão2018-10-27

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-10-27 under 510(k) number K180980. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is a medical device that received FDA 510(k) clearance on 2018-10-27. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K180980.

When did ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System receive FDA 510(k) clearance?

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System received FDA 510(k) clearance on 2018-10-27, under 510(k) number K180980.

Who is the listed applicant for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

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

What is the FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System?

The FDA product code for ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is NKB.

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Outros registros que listam Camber Spine Technologies, LLC como candidato(a)

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Fonte oficial

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