FDA 510(k)

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

Номер K: K160020 · 2016-03-02

Дата решения2016-03-02

Код продуктаMNH

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K160020. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Captiva Spine. The 510(k) number is K160020.

When did Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System receive FDA 510(k) clearance?

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System received FDA 510(k) clearance on 2016-03-02, under 510(k) number K160020.

Who is the listed applicant for Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

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

What is the FDA product code for Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

The FDA product code for Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is MNH. This falls under the ENT category.

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: MNH)

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I Corporation K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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.