FDA 510(k)

The JASPER Spinal Fixation System II

Número K: K190762 · 2019-06-19

Data da decisão2019-06-19

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

The JASPER Spinal Fixation System II is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190762. 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 The JASPER Spinal Fixation System II?

The JASPER Spinal Fixation System II is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K190762.

When did The JASPER Spinal Fixation System II receive FDA 510(k) clearance?

The JASPER Spinal Fixation System II received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190762.

Who is the listed applicant for The JASPER Spinal Fixation System II?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The JASPER Spinal Fixation System II?

The FDA product code for The JASPER Spinal Fixation System II is NKB.

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Fonte oficial

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