FDA 510(k)

Biomet Microfixation SternaLock 360 Sternal Closure System

Número K: K163007 · 2016-11-23

Data da decisão2016-11-23

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biomet Microfixation SternaLock 360 Sternal Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K163007. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biomet Microfixation SternaLock 360 Sternal Closure System?

Biomet Microfixation SternaLock 360 Sternal Closure System is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Biomet Microfixation. The 510(k) number is K163007.

When did Biomet Microfixation SternaLock 360 Sternal Closure System receive FDA 510(k) clearance?

Biomet Microfixation SternaLock 360 Sternal Closure System received FDA 510(k) clearance on 2016-11-23, under 510(k) number K163007.

Who is the listed applicant for Biomet Microfixation SternaLock 360 Sternal Closure System?

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

What is the FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System?

The FDA product code for Biomet Microfixation SternaLock 360 Sternal Closure System is HRS.

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Fonte oficial

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