FDA 510(k)

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

Número K: K232586 · 2023-10-24

Data da decisão2023-10-24

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232586. 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 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is K&J Consulting Corp.. The 510(k) number is K232586.

When did Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System receive FDA 510(k) clearance?

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232586.

Who is the listed applicant for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

The FDA 510(k) record lists K&J Consulting Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System?

The FDA product code for Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is NKB.

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Outros registros que listam K&J Consulting Corp. como candidato(a)

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Fonte oficial

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