FDA 510(k)

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

N.º K: K260340 · 2026-04-13

Fecha de decisión2026-04-13

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES is the device name listed in this FDA 510(k) record. The listed applicant is HC Biologics, LLC. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K260340. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES?

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is HC Biologics, LLC. The 510(k) number is K260340.

When did HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES receive FDA 510(k) clearance?

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES received FDA 510(k) clearance on 2026-04-13, under 510(k) number K260340.

Who is the listed applicant for HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES?

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

What is the FDA product code for HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES?

The FDA product code for HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES is ODP.

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Otros registros que enlistan a HC Biologics, LLC como solicitante

K250092HC Biologics Osteopoint Spinal Fixation System

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Fuente oficial

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