FDA 510(k)

VerteGlide Spinal Growth Guidance System

Número K: K241816 · 2025-03-14

Data da decisão2025-03-14

Código do produtoPGM

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VerteGlide Spinal Growth Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K241816. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VerteGlide Spinal Growth Guidance System?

VerteGlide Spinal Growth Guidance System is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K241816.

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

VerteGlide Spinal Growth Guidance System received FDA 510(k) clearance on 2025-03-14, under 510(k) number K241816.

Who is the listed applicant for VerteGlide Spinal Growth Guidance System?

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

What is the FDA product code for VerteGlide Spinal Growth Guidance System?

The FDA product code for VerteGlide Spinal Growth Guidance System is PGM.

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Fonte oficial

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