FDA 510(k)

Mini-OSTEO Pedicle Fixation System

Номер K: K231443 · 2023-11-21

ЗаявительOsteomed Indústria E Comércio DE Implantes Ltda

Дата решения2023-11-21

Код продуктаNKB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Mini-OSTEO Pedicle Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K231443. 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 Mini-OSTEO Pedicle Fixation System?

Mini-OSTEO Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Osteomed Indústria E Comércio DE Implantes Ltda. The 510(k) number is K231443.

When did Mini-OSTEO Pedicle Fixation System receive FDA 510(k) clearance?

Mini-OSTEO Pedicle Fixation System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K231443.

Who is the listed applicant for Mini-OSTEO Pedicle Fixation System?

The FDA 510(k) record lists Osteomed Indústria E Comércio DE Implantes Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini-OSTEO Pedicle Fixation System?

The FDA product code for Mini-OSTEO Pedicle 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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