FDA 510(k)

EMPHASYS Acetabular System

Número K: K243977 · 2025-01-22

Data da decisão2025-01-22

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMPHASYS Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243977. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EMPHASYS Acetabular System?

EMPHASYS Acetabular System is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Depuy Ireland UC. The 510(k) number is K243977.

When did EMPHASYS Acetabular System receive FDA 510(k) clearance?

EMPHASYS Acetabular System received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243977.

Who is the listed applicant for EMPHASYS Acetabular System?

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

What is the FDA product code for EMPHASYS Acetabular System?

The FDA product code for EMPHASYS Acetabular System is LPH.

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 Depuy Ireland UC como candidato(a)

K260480VELYS™ Robotic-Assisted Solution K261458ATTUNE Sistema de Quadril Total; ATTUNE Sistema de Quadril Cimentado K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K253624INHANCE™ Reverse Shoulder System K253551VELYS™ Hip Navigation K253197ATTUNE™ Sistema de Quadril Total; ATTUNE™ Mangueira de Revisão LPS™ Adaptadores Femorais

Ver todos os 50 dispositivos →

Dispositivos Relacionados (Código: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, 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.