FDA 510(k)

M6-C™ Single Use, Disposable Instrumentation

Número K: K241117 · 2024-06-21

RequerenteSpinal Kinetics / Orthofix / Seaspine

Data da decisão2024-06-21

Código do produtoQLQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

M6-C™ Single Use, Disposable Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K241117. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the M6-C™ Single Use, Disposable Instrumentation?

M6-C™ Single Use, Disposable Instrumentation is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. The 510(k) number is K241117.

When did M6-C™ Single Use, Disposable Instrumentation receive FDA 510(k) clearance?

M6-C™ Single Use, Disposable Instrumentation received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241117.

Who is the listed applicant for M6-C™ Single Use, Disposable Instrumentation?

The FDA 510(k) record lists Spinal Kinetics / Orthofix / Seaspine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M6-C™ Single Use, Disposable Instrumentation?

The FDA product code for M6-C™ Single Use, Disposable Instrumentation is QLQ.

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Fonte oficial

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