FDA 510(k)

Placa de Bloqueo de Espiga APS

N.º K: K254053 · 2026-03-17

SolicitanteA Plus Biotechnology Co., Ltd.

Fecha de decisión2026-03-17

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

APS Spear Locking Plate is the device name listed in this FDA 510(k) record. The listed applicant is A Plus Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K254053. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the APS Spear Locking Plate?

APS Spear Locking Plate is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K254053.

When did APS Spear Locking Plate receive FDA 510(k) clearance?

APS Spear Locking Plate received FDA 510(k) clearance on 2026-03-17, under 510(k) number K254053.

Who is the listed applicant for APS Spear Locking Plate?

The FDA 510(k) record lists A Plus Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APS Spear Locking Plate?

The FDA product code for APS Spear Locking Plate is HRS.

Ensayos clínicos relacionados

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Otros registros que enlistan a A Plus Biotechnology Co., Ltd. como solicitante

K252897Sistema de Fijación de Osteotomía APS (0945-1302-xx / Tornillo Cortex de 4.5mm); Sistema de Fijación de Osteotomía APS (0850-4302-xx / Tornillo Bloqueo de 5.0mm); Sistema de Fijación de Osteotomía APS (0701-xx10(1)-05 / Placa de Osteotomía Media Proximal Tibial Bloqueo); Sistema de Fijación de Osteotomía APS (0701-xx60(1)-0x / Placa de Osteotomía Media Proximal Tibial Bloqueo, Pequeña); Sistema de Fijación de Osteotomía APS (0702-xx00(1)-03 / Placa de Osteotomía Lateral Proximal Tibial Bloqueo); Sistema de Fijación de Osteotomía APS (0501-xx00(1)-04 / Dista)K223150Placa Metálica y Sistema de Tornillos APS

Dispositivos relacionados (Código: HRS)

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Fuente oficial

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