FDA 510(k)

RedPoint Medical's Better Bunion System

Номер K: K220717 · 2022-06-09

Дата решения2022-06-09

Код продуктаPBF

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

RedPoint Medical's Better Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Redpoint Medical, LLC. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K220717. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the RedPoint Medical's Better Bunion System?

RedPoint Medical's Better Bunion System is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Redpoint Medical, LLC. The 510(k) number is K220717.

When did RedPoint Medical's Better Bunion System receive FDA 510(k) clearance?

RedPoint Medical's Better Bunion System received FDA 510(k) clearance on 2022-06-09, under 510(k) number K220717.

Who is the listed applicant for RedPoint Medical's Better Bunion System?

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

What is the FDA product code for RedPoint Medical's Better Bunion System?

The FDA product code for RedPoint Medical's Better Bunion System is PBF.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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

Связанные устройства (Код: PBF)

K252064MedCAD® AccuStride™ SystemMedcad K250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcad K250394Fine TTO™Bodycad Laboratories, Inc.K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.