FDA 510(k)

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

Número K: K171456 · 2017-08-03

Data da decisão2017-08-03

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K171456. 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 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Choicespine. The 510(k) number is K171456.

When did Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems receive FDA 510(k) clearance?

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems received FDA 510(k) clearance on 2017-08-03, under 510(k) number K171456.

Who is the listed applicant for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

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

What is the FDA product code for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

The FDA product code for Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is NKB.

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Outros registros que listam Choicespine como candidato(a)

K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) System K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System

Dispositivos Relacionados (Código: NKB)

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