FDA 510(k)

SMART Osteotomy System

Número K: K260090 · 2026-04-10

Data da decisão2026-04-10

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SMART Osteotomy System is the device name listed in this FDA 510(k) record. The listed applicant is Actis Medical Pty., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260090. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SMART Osteotomy System?

SMART Osteotomy System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Actis Medical Pty., Ltd.. The 510(k) number is K260090.

When did SMART Osteotomy System receive FDA 510(k) clearance?

SMART Osteotomy System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260090.

Who is the listed applicant for SMART Osteotomy System?

The FDA 510(k) record lists Actis Medical Pty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART Osteotomy System?

The FDA product code for SMART Osteotomy System is HRS.

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: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.