FDA 510(k)

OIC Small / Mini Fragment Plate System

Número K: K242995 · 2024-10-23

RequerenteThe Orthopaedic Implant Company

Data da decisão2024-10-23

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OIC Small / Mini Fragment Plate System is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K242995. 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 OIC Small / Mini Fragment Plate System?

OIC Small / Mini Fragment Plate System is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is The Orthopaedic Implant Company. The 510(k) number is K242995.

When did OIC Small / Mini Fragment Plate System receive FDA 510(k) clearance?

OIC Small / Mini Fragment Plate System received FDA 510(k) clearance on 2024-10-23, under 510(k) number K242995.

Who is the listed applicant for OIC Small / Mini Fragment Plate System?

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

What is the FDA product code for OIC Small / Mini Fragment Plate System?

The FDA product code for OIC Small / Mini Fragment Plate System is HRS.

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Fonte oficial

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