FDA 510(k)

ZipToe™ Hammertoe Fusion System

Número K: K253325 · 2025-12-29

Data da decisão2025-12-29

Código do produtoHTY

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZipToe™ Hammertoe Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Toetal Solutions. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K253325. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZipToe™ Hammertoe Fusion System?

ZipToe™ Hammertoe Fusion System is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Toetal Solutions. The 510(k) number is K253325.

When did ZipToe™ Hammertoe Fusion System receive FDA 510(k) clearance?

ZipToe™ Hammertoe Fusion System received FDA 510(k) clearance on 2025-12-29, under 510(k) number K253325.

Who is the listed applicant for ZipToe™ Hammertoe Fusion System?

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

What is the FDA product code for ZipToe™ Hammertoe Fusion System?

The FDA product code for ZipToe™ Hammertoe Fusion System is HTY.

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: HTY)

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies K241014Biomet Kirschner Wires (K-Wires)Biomet, 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.