FDA 510(k)

C柄 EMPOWR™

Número K: K223779 · 2023-02-13

Data da decisão2023-02-13

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMPOWR™ blade stem is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223779. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EMPOWR™ blade stem?

EMPOWR™ blade stem is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Encore Medical, LLC. The 510(k) number is K223779.

When did EMPOWR™ blade stem receive FDA 510(k) clearance?

EMPOWR™ blade stem received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223779.

Who is the listed applicant for EMPOWR™ blade stem?

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

What is the FDA product code for EMPOWR™ blade stem?

The FDA product code for EMPOWR™ blade stem is LPH.

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Fonte oficial

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