FDA 510(k)

Sistema Espinal

Número K: K240963 · 2024-06-06

Data da decisão2024-06-06

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Teslake, Inc.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K240963. 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 Spinal System?

Spinal System is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Teslake, Inc.. The 510(k) number is K240963.

When did Spinal System receive FDA 510(k) clearance?

Spinal System received FDA 510(k) clearance on 2024-06-06, under 510(k) number K240963.

Who is the listed applicant for Spinal System?

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

What is the FDA product code for Spinal System?

The FDA product code for Spinal System is NKB.

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Fonte oficial

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