FDA 510(k)

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

Número K: K251154 · 2025-06-12

RequerenteHt Medical D.B.A. Xenix Medical

Data da decisão2025-06-12

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251154. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K251154.

When did RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments receive FDA 510(k) clearance?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251154.

Who is the listed applicant for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is NKB.

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Outros registros que listam Ht Medical D.B.A. Xenix Medical como candidato(a)

K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical K231829Xenix Medical Sacroiliac Fixation System

Dispositivos Relacionados (Código: NKB)

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Fonte oficial

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