FDA 510(k)

Reselute Tibial Nail

Número K: K253517 · 2026-03-10

Data da decisão2026-03-10

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reselute Tibial Nail is the device name listed in this FDA 510(k) record. The listed applicant is Reselute, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K253517. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reselute Tibial Nail?

Reselute Tibial Nail is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Reselute, Inc.. The 510(k) number is K253517.

When did Reselute Tibial Nail receive FDA 510(k) clearance?

Reselute Tibial Nail received FDA 510(k) clearance on 2026-03-10, under 510(k) number K253517.

Who is the listed applicant for Reselute Tibial Nail?

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

What is the FDA product code for Reselute Tibial Nail?

The FDA product code for Reselute Tibial Nail is HSB.

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

Dispositivos Relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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.