FDA 510(k)

Bony Trauma Extremity System (BTES) Screw Range, NX Nail

Número K: K230118 · 2023-02-16

Data da decisão2023-02-16

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is the device name listed in this FDA 510(k) record. The listed applicant is Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K230118. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Field Orthopaedics Pty, Ltd.. The 510(k) number is K230118.

When did Bony Trauma Extremity System (BTES) Screw Range, NX Nail receive FDA 510(k) clearance?

Bony Trauma Extremity System (BTES) Screw Range, NX Nail received FDA 510(k) clearance on 2023-02-16, under 510(k) number K230118.

Who is the listed applicant for Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

The FDA 510(k) record lists Field Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail?

The FDA product code for Bony Trauma Extremity System (BTES) Screw Range, NX Nail is HWC. This falls under the Cardiovascular category.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Field Orthopaedics Pty, Ltd. como candidato(a)

K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range K180348Field Orthopaedics Micro Screw System

Dispositivos Relacionados (Código: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.