FDA 510(k)

Orbitum Bone Staple Implant, X and VI

Número K: K173693 · 2018-02-23

Data da decisão2018-02-23

Código do produtoJDR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Orbitum Bone Staple Implant, X and VI is the device name listed in this FDA 510(k) record. The listed applicant is Orthovestments, LLC. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173693. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Orbitum Bone Staple Implant, X and VI?

Orbitum Bone Staple Implant, X and VI is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Orthovestments, LLC. The 510(k) number is K173693.

When did Orbitum Bone Staple Implant, X and VI receive FDA 510(k) clearance?

Orbitum Bone Staple Implant, X and VI received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173693.

Who is the listed applicant for Orbitum Bone Staple Implant, X and VI?

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

What is the FDA product code for Orbitum Bone Staple Implant, X and VI?

The FDA product code for Orbitum Bone Staple Implant, X and VI is JDR.

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

Dispositivos Relacionados (Código: JDR)

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax Surgical K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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.