FDA 510(k)

Montross Extremity Medical Hemi Implant System

Número K: K221220 · 2023-04-19

Data da decisão2023-04-19

Código do produtoKWD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Montross Extremity Medical Hemi Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Montross Extremity Medical. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K221220. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Montross Extremity Medical Hemi Implant System?

Montross Extremity Medical Hemi Implant System is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Montross Extremity Medical. The 510(k) number is K221220.

When did Montross Extremity Medical Hemi Implant System receive FDA 510(k) clearance?

Montross Extremity Medical Hemi Implant System received FDA 510(k) clearance on 2023-04-19, under 510(k) number K221220.

Who is the listed applicant for Montross Extremity Medical Hemi Implant System?

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

What is the FDA product code for Montross Extremity Medical Hemi Implant System?

The FDA product code for Montross Extremity Medical Hemi Implant System is KWD.

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: KWD)

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Implante Hemi Accu-JointAccufix Surgical, Inc.K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC K201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K200951Implante Hemi Accu-JointAccufix Surgical, 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.