FDA 510(k)

FORTEZZA Spinal Stabilization System

Номер K: K162576 · 2016-11-10

Дата решения2016-11-10

Код продуктаNKB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

FORTEZZA Spinal Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Osso Surgical. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162576. 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 FORTEZZA Spinal Stabilization System?

FORTEZZA Spinal Stabilization System is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Osso Surgical. The 510(k) number is K162576.

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

FORTEZZA Spinal Stabilization System received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162576.

Who is the listed applicant for FORTEZZA Spinal Stabilization System?

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

What is the FDA product code for FORTEZZA Spinal Stabilization System?

The FDA product code for FORTEZZA Spinal Stabilization 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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