FDA 510(k)

OmniPore DUROMAX Surgical Implants

Número K: K180249 · 2018-10-11

RequerenteMatrix Surgical Holdings, LLC/Matrix Surgical USA

Data da decisão2018-10-11

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OmniPore DUROMAX Surgical Implants is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K180249. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OmniPore DUROMAX Surgical Implants?

OmniPore DUROMAX Surgical Implants is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. The 510(k) number is K180249.

When did OmniPore DUROMAX Surgical Implants receive FDA 510(k) clearance?

OmniPore DUROMAX Surgical Implants received FDA 510(k) clearance on 2018-10-11, under 510(k) number K180249.

Who is the listed applicant for OmniPore DUROMAX Surgical Implants?

The FDA 510(k) record lists Matrix Surgical Holdings, LLC/Matrix Surgical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniPore DUROMAX Surgical Implants?

The FDA product code for OmniPore DUROMAX Surgical Implants is JEY.

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