FDA 510(k)

NeoFuse HA Enhanced PLIF/TLIF

Número K: K170511 · 2017-04-25

Data da decisão2017-04-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeoFuse HA Enhanced PLIF/TLIF is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K170511. 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 NeoFuse HA Enhanced PLIF/TLIF?

NeoFuse HA Enhanced PLIF/TLIF is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Ht Medical, LLC. The 510(k) number is K170511.

When did NeoFuse HA Enhanced PLIF/TLIF receive FDA 510(k) clearance?

NeoFuse HA Enhanced PLIF/TLIF received FDA 510(k) clearance on 2017-04-25, under 510(k) number K170511.

Who is the listed applicant for NeoFuse HA Enhanced PLIF/TLIF?

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

What is the FDA product code for NeoFuse HA Enhanced PLIF/TLIF?

The FDA product code for NeoFuse HA Enhanced PLIF/TLIF is MAX.

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

K170318NeoFuse Ti3D PLIF/TLIF/Cervical Interbody K153615NeoFuse HA Enhanced PLIF/TLIF

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Fonte oficial

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