FDA 510(k)

Vertex Hip Fracture Nailing System

Número K: K233910 · 2024-04-04

Data da decisão2024-04-04

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vertex Hip Fracture Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Orthoxel Dac. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233910. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vertex Hip Fracture Nailing System?

Vertex Hip Fracture Nailing System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Orthoxel Dac. The 510(k) number is K233910.

When did Vertex Hip Fracture Nailing System receive FDA 510(k) clearance?

Vertex Hip Fracture Nailing System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233910.

Who is the listed applicant for Vertex Hip Fracture Nailing System?

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

What is the FDA product code for Vertex Hip Fracture Nailing System?

The FDA product code for Vertex Hip Fracture Nailing System is HSB.

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