FDA 510(k)

Reef L Interbody System; WaveForm L Interbody System

Número K: K240566 · 2024-04-26

RequerenteSeaSpine Orthopedics Corporation

Data da decisão2024-04-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reef L Interbody System; WaveForm L Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240566. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reef L Interbody System; WaveForm L Interbody System?

Reef L Interbody System; WaveForm L Interbody System is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K240566.

When did Reef L Interbody System; WaveForm L Interbody System receive FDA 510(k) clearance?

Reef L Interbody System; WaveForm L Interbody System received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240566.

Who is the listed applicant for Reef L Interbody System; WaveForm L Interbody System?

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

What is the FDA product code for Reef L Interbody System; WaveForm L Interbody System?

The FDA product code for Reef L Interbody System; WaveForm L Interbody System is MAX.

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Fonte oficial

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