FDA 510(k)

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

Número K: K180665 · 2018-11-28

Data da decisão2018-11-28

Código do produtoMQP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, LLC. It received FDA 510(k) clearance on 2018-11-28 under 510(k) number K180665. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is K2m, LLC. The 510(k) number is K180665.

When did SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System receive FDA 510(k) clearance?

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System received FDA 510(k) clearance on 2018-11-28, under 510(k) number K180665.

Who is the listed applicant for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?

The FDA 510(k) record lists K2m, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?

The FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is MQP.

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