FDA 510(k)

Universal Mesh - Sterile

Número K: K182425 · 2018-11-06

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2018-11-06

Código do produtoGWO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Universal Mesh - Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K182425. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Universal Mesh - Sterile?

Universal Mesh - Sterile is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K182425.

When did Universal Mesh - Sterile receive FDA 510(k) clearance?

Universal Mesh - Sterile received FDA 510(k) clearance on 2018-11-06, under 510(k) number K182425.

Who is the listed applicant for Universal Mesh - Sterile?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal Mesh - Sterile?

The FDA product code for Universal Mesh - Sterile is GWO.

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 Stryker Leibinger GmbH & Co KG como candidato(a)

K261054RibPlate System K254233MEDPOR Customized Implant Kit K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories K243491SternalPlate Expansion K241517Q Guidance System; Mako Spine System;

Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: GWO)

K262874CraniUS PlateCraniUS, LLC K261058CraniUS PlateCraniUS, LLC K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391Sistema de Fixação Neurológica MCI-NeuroMci Medical Concept Innovation, 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.