FDA 510(k)

Materialise TKA Guide System

Número K: K251554 · 2025-07-14

Data da decisão2025-07-14

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Materialise TKA Guide System is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K251554. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Materialise TKA Guide System?

Materialise TKA Guide System is a medical device that received FDA 510(k) clearance on 2025-07-14. The listed applicant is Materialise NV. The 510(k) number is K251554.

When did Materialise TKA Guide System receive FDA 510(k) clearance?

Materialise TKA Guide System received FDA 510(k) clearance on 2025-07-14, under 510(k) number K251554.

Who is the listed applicant for Materialise TKA Guide System?

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

What is the FDA product code for Materialise TKA Guide System?

The FDA product code for Materialise TKA Guide System is JWH.

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 Materialise NV como candidato(a)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Ver todos os 34 dispositivos →

Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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.