FDA 510(k)

Fêmur Inversa AltiVate, 48mm

Número K: K190290 · 2019-04-26

Data da decisão2019-04-26

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AltiVate Reverse Humeral Stem, 48mm is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K190290. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AltiVate Reverse Humeral Stem, 48mm?

AltiVate Reverse Humeral Stem, 48mm is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Encore Medical L.P.. The 510(k) number is K190290.

When did AltiVate Reverse Humeral Stem, 48mm receive FDA 510(k) clearance?

AltiVate Reverse Humeral Stem, 48mm received FDA 510(k) clearance on 2019-04-26, under 510(k) number K190290.

Who is the listed applicant for AltiVate Reverse Humeral Stem, 48mm?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AltiVate Reverse Humeral Stem, 48mm?

The FDA product code for AltiVate Reverse Humeral Stem, 48mm is KWS.

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 Encore Medical L.P. como candidato(a)

K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141AltiVate Reverse® Glenoid K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

Ver todos os 31 dispositivos →

Dispositivos Relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Ombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótese Metacôndila AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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.