FDA 510(k)

Adaptix® PEEK Interbody System com Nanotecnologia; Sistema de Coluna Espinal Capstone Control® PEEK com Nanotecnologia

Número K: K241605 · 2024-09-05

Data da decisão2024-09-05

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K241605. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology?

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Nanovis, LLC. The 510(k) number is K241605.

When did Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology receive FDA 510(k) clearance?

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology received FDA 510(k) clearance on 2024-09-05, under 510(k) number K241605.

Who is the listed applicant for Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology?

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

What is the FDA product code for Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology?

The FDA product code for Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology is MAX.

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Outros registros que listam Nanovis, LLC como candidato(a)

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Fonte oficial

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