FDA 510(k)

4CIS SARA Spine System, 4CIS VERTU Spine System

Número K: K202498 · 2021-02-18

RequerenteSolco Biomedical Company India Private Limited

Data da decisão2021-02-18

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

4CIS SARA Spine System, 4CIS VERTU Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202498. 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 4CIS SARA Spine System, 4CIS VERTU Spine System?

4CIS SARA Spine System, 4CIS VERTU Spine System is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Solco Biomedical Company India Private Limited. The 510(k) number is K202498.

When did 4CIS SARA Spine System, 4CIS VERTU Spine System receive FDA 510(k) clearance?

4CIS SARA Spine System, 4CIS VERTU Spine System received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202498.

Who is the listed applicant for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA 510(k) record lists Solco Biomedical Company India Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System is NKB.

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Fonte oficial

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