FDA 510(k)

Mini-OSTEO Pedicle Fixation System

Número K: K231443 · 2023-11-21

RequerenteOsteomed Indústria E Comércio DE Implantes Ltda

Data da decisão2023-11-21

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mini-OSTEO Pedicle Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K231443. 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 Mini-OSTEO Pedicle Fixation System?

Mini-OSTEO Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. The 510(k) number is K231443.

When did Mini-OSTEO Pedicle Fixation System receive FDA 510(k) clearance?

Mini-OSTEO Pedicle Fixation System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K231443.

Who is the listed applicant for Mini-OSTEO Pedicle Fixation System?

The FDA 510(k) record lists Osteomed Indústria E Comércio DE Implantes Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini-OSTEO Pedicle Fixation System?

The FDA product code for Mini-OSTEO Pedicle Fixation System is NKB.

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