FDA 510(k)

“Socko” Vimax Spinal Fixation System

Número K: K253045 · 2026-06-17

Data da decisão2026-06-17

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

“Socko” Vimax Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Socko Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253045. 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 “Socko” Vimax Spinal Fixation System?

“Socko” Vimax Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Socko Medical Co., Ltd.. The 510(k) number is K253045.

When did “Socko” Vimax Spinal Fixation System receive FDA 510(k) clearance?

“Socko” Vimax Spinal Fixation System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253045.

Who is the listed applicant for “Socko” Vimax Spinal Fixation System?

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

What is the FDA product code for “Socko” Vimax Spinal Fixation System?

The FDA product code for “Socko” Vimax Spinal Fixation System is NKB.

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Fonte oficial

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