FDA 510(k)

Система хирургического оборудования 7D - подкожное применение (7D Flash Frame)

Номер K: K220522 · 2022-05-20

Заявитель7D Surgical

Дата решения2022-05-20

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

7D Surgical System - Percutaneous Application (7D Flash Frame) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220522. 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 7D Surgical System - Percutaneous Application (7D Flash Frame)?

7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is 7D Surgical. The 510(k) number is K220522.

When did 7D Surgical System - Percutaneous Application (7D Flash Frame) receive FDA 510(k) clearance?

7D Surgical System - Percutaneous Application (7D Flash Frame) received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220522.

Who is the listed applicant for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA 510(k) record lists 7D Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame) 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.

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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

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