FDA 510(k)

Tornier Humeral Reconstruction System (Tornier HRS)

Número K: K241609 · 2024-09-10

RequerenteStryker Corporation (Tornier, Inc.)

Data da decisão2024-09-10

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tornier Humeral Reconstruction System (Tornier HRS) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K241609. 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 Tornier Humeral Reconstruction System (Tornier HRS)?

Tornier Humeral Reconstruction System (Tornier HRS) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241609.

When did Tornier Humeral Reconstruction System (Tornier HRS) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K241609.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS)?

The FDA 510(k) record lists Stryker Corporation (Tornier, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS) 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 Stryker Corporation (Tornier, Inc.) como candidato(a)

K260102Tornier Perform Reversed Glenoid e Tornier Perform Reversed Augmented Glenoid Shoulder System K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

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.