FDA 510(k)

Stryker Resorbable Fixation System

Номер K: K213777 · 2022-02-04

ЗаявительStryker Leibinger Micro Implants

Дата решения2022-02-04

Код продуктаJEY

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Stryker Resorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger Micro Implants. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213777. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Stryker Resorbable Fixation System?

Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Stryker Leibinger Micro Implants. The 510(k) number is K213777.

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

Stryker Resorbable Fixation System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213777.

Who is the listed applicant for Stryker Resorbable Fixation System?

The FDA 510(k) record lists Stryker Leibinger Micro Implants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Resorbable Fixation System?

The FDA product code for Stryker Resorbable Fixation System is JEY.

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: JEY)

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical Corporation K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Официальный источник

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