FDA 510(k)

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

Número K: K230831 · 2023-11-13

Data da decisão2023-11-13

Código do produtoMBF

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid 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 2023-11-13 under 510(k) number K230831. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Depuy Ireland UC. The 510(k) number is K230831.

When did INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid receive FDA 510(k) clearance?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid received FDA 510(k) clearance on 2023-11-13, under 510(k) number K230831.

Who is the listed applicant for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

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 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

The FDA product code for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is MBF.

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: MBF)

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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.