FDA 510(k)

Sistema de Placa Metálica e Parafuso APS

Número K: K223150 · 2023-08-24

RequerenteA Plus Biotechnology Co., Ltd.

Data da decisão2023-08-24

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

APS Metal Plate & Screw System 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 2023-08-24 under 510(k) number K223150. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the APS Metal Plate & Screw System?

APS Metal Plate & Screw System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is A Plus Biotechnology Co., Ltd.. The 510(k) number is K223150.

When did APS Metal Plate & Screw System receive FDA 510(k) clearance?

APS Metal Plate & Screw System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K223150.

Who is the listed applicant for APS Metal Plate & Screw System?

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 Metal Plate & Screw System?

The FDA product code for APS Metal Plate & Screw System is HRS.

Ensaios clínicos relacionados

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Outros registros que listam A Plus Biotechnology Co., Ltd. como candidato(a)

K254053Placa de Bloqueio APS Spear K252897Sistema de Fixação de Osteotomia APS (0945-1302-xx / Parafuso Cortex 4.5mm); Sistema de Fixação de Osteotomia APS (0850-4302-xx / Parafuso Bloqueável 5.0mm); Sistema de Fixação de Osteotomia APS (0701-xx10(1)-05 / Placa de Bloqueio de Osteotomia Tibial Medial Proximal); Sistema de Fixação de Osteotomia APS (0701-xx60(1)-0x / Placa de Bloqueio de Osteotomia Tibial Medial Proximal, Pequena); Sistema de Fixação de Osteotomia APS (0702-xx00(1)-03 / Placa de Bloqueio de Osteotomia Tibial Lateral Proximal); Sistema de Fixação de Osteotomia APS (0501-xx00(1)-04 / Distal)

Dispositivos Relacionados (Código: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Fonte oficial

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