FDA 510(k)

Kentrospine PSS Pedicle Screw System

Номер K: K220486 · 2022-07-22

Дата решения2022-07-22

Код продуктаNKB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Kentrospine PSS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Rivarp Medical Private Limited. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K220486. 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 Kentrospine PSS Pedicle Screw System?

Kentrospine PSS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Rivarp Medical Private Limited. The 510(k) number is K220486.

When did Kentrospine PSS Pedicle Screw System receive FDA 510(k) clearance?

Kentrospine PSS Pedicle Screw System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K220486.

Who is the listed applicant for Kentrospine PSS Pedicle Screw System?

The FDA 510(k) record lists Rivarp Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kentrospine PSS Pedicle Screw System?

The FDA product code for Kentrospine PSS Pedicle Screw 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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