FDA 510(k)

MEGAFIX® Pedicle Screw Spinal System

Номер K: K191655 · 2020-03-06

Дата решения2020-03-06

Код продуктаNKB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

MEGAFIX® Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Seohancare Co., Ltd.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K191655. 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 MEGAFIX® Pedicle Screw Spinal System?

MEGAFIX® Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Seohancare Co., Ltd.. The 510(k) number is K191655.

When did MEGAFIX® Pedicle Screw Spinal System receive FDA 510(k) clearance?

MEGAFIX® Pedicle Screw Spinal System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K191655.

Who is the listed applicant for MEGAFIX® Pedicle Screw Spinal System?

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

What is the FDA product code for MEGAFIX® Pedicle Screw Spinal System?

The FDA product code for MEGAFIX® Pedicle Screw Spinal 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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