FDA 510(k)

LOCK-IN Spinal Fixation System

Número K: K243281 · 2024-12-13

Data da decisão2024-12-13

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOCK-IN Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Lock-In USA Corp. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K243281. 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 LOCK-IN Spinal Fixation System?

LOCK-IN Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Lock-In USA Corp. The 510(k) number is K243281.

When did LOCK-IN Spinal Fixation System receive FDA 510(k) clearance?

LOCK-IN Spinal Fixation System received FDA 510(k) clearance on 2024-12-13, under 510(k) number K243281.

Who is the listed applicant for LOCK-IN Spinal Fixation System?

The FDA 510(k) record lists Lock-In USA Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOCK-IN Spinal Fixation System?

The FDA product code for LOCK-IN Spinal Fixation System is NKB.

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