FDA 510(k)

NanoHive Medical Lumbar Interbody System

Número K: K231241 · 2023-07-12

Data da decisão2023-07-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NanoHive Medical Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is NanoHive Medical, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K231241. 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 NanoHive Medical Lumbar Interbody System?

NanoHive Medical Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is NanoHive Medical, LLC. The 510(k) number is K231241.

When did NanoHive Medical Lumbar Interbody System receive FDA 510(k) clearance?

NanoHive Medical Lumbar Interbody System received FDA 510(k) clearance on 2023-07-12, under 510(k) number K231241.

Who is the listed applicant for NanoHive Medical Lumbar Interbody System?

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

What is the FDA product code for NanoHive Medical Lumbar Interbody System?

The FDA product code for NanoHive Medical Lumbar Interbody System is MAX.

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Outros registros que listam NanoHive Medical, LLC como candidato(a)

K254105Hive™ Standalone Cervical System and Hive™ C Interbody System K223190Hive™ Standalone Cervical System

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Fonte oficial

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