FDA 510(k)

Spinal Fixation System

Номер K: K190408 · 2020-06-16

ЗаявительShangdong Kangsheng Medical Devices Co., Ltd.

Дата решения2020-06-16

Код продуктаNKB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Kangsheng Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2020-06-16 under 510(k) number K190408. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Spinal Fixation System?

Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-06-16. The listed applicant is Shangdong Kangsheng Medical Devices Co., Ltd.. The 510(k) number is K190408.

When did Spinal Fixation System receive FDA 510(k) clearance?

Spinal Fixation System received FDA 510(k) clearance on 2020-06-16, under 510(k) number K190408.

Who is the listed applicant for Spinal Fixation System?

The FDA 510(k) record lists Shangdong Kangsheng Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinal Fixation System?

The FDA product code for Spinal Fixation System is NKB.

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: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Официальный источник

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