FDA 510(k)

MOTO Partial Knee System Extension

Número K: K251618 · 2025-07-24

Data da decisão2025-07-24

Código do produtoHSX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MOTO Partial Knee System Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K251618. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MOTO Partial Knee System Extension?

MOTO Partial Knee System Extension is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Medacta International S.A.. The 510(k) number is K251618.

When did MOTO Partial Knee System Extension receive FDA 510(k) clearance?

MOTO Partial Knee System Extension received FDA 510(k) clearance on 2025-07-24, under 510(k) number K251618.

Who is the listed applicant for MOTO Partial Knee System Extension?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOTO Partial Knee System Extension?

The FDA product code for MOTO Partial Knee System Extension is HSX.

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 Medacta International S.A. como candidato(a)

K260173M-Vizion Femoral Revision System Extension K253630Mpact 3D Metal Foam K254202MectaLIF 3D Metal Anterior K253940M.U.S.T. Pedicle Screw System - Extension K253328GMK 3D Metal Tibial Tray Extension K250644MSS - Monobloc stem

Ver todos os 148 dispositivos →

Dispositivos Relacionados (Código: HSX)

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer Biomet K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260Sistema de Quadril Unicôndilo ACTIFY™Globus Medical, 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.