FDA 510(k)

RobPath® Total Hip Application

Номер K: K220774 · 2022-12-09

ЗаявительHangzhou Lancet Robotics Co., Ltd.

Дата решения2022-12-09

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

RobPath® Total Hip Application is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Lancet Robotics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K220774. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the RobPath® Total Hip Application?

RobPath® Total Hip Application is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Hangzhou Lancet Robotics Co., Ltd.. The 510(k) number is K220774.

When did RobPath® Total Hip Application receive FDA 510(k) clearance?

RobPath® Total Hip Application received FDA 510(k) clearance on 2022-12-09, under 510(k) number K220774.

Who is the listed applicant for RobPath® Total Hip Application?

The FDA 510(k) record lists Hangzhou Lancet Robotics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RobPath® Total Hip Application?

The FDA product code for RobPath® Total Hip Application is OLO.

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: OLO)

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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.