FDA 510(k)

GSPE Spacer

N.º K: K260063 · 2026-09-11

SolicitanteThe General Hospital Corporation, d/b/a Massachusetts

Fecha de decisión2026-09-11

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

GSPE Spacer is the device name listed in this FDA 510(k) record. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K260063. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GSPE Spacer?

GSPE Spacer is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. The 510(k) number is K260063.

When did GSPE Spacer receive FDA 510(k) clearance?

GSPE Spacer received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260063.

Who is the listed applicant for GSPE Spacer?

The FDA 510(k) record lists The General Hospital Corporation, d/b/a Massachusetts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSPE Spacer?

The FDA product code for GSPE Spacer is JWH.

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Fuente oficial

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