FDA 510(k)

Stryker Facial iD System

Номер K: K232350 · 2024-01-13

Дата решения2024-01-13

Код продуктаJEY

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Stryker Facial iD System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial. It received FDA 510(k) clearance on 2024-01-13 under 510(k) number K232350. 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 Facial iD System?

Stryker Facial iD System is a medical device that received FDA 510(k) clearance on 2024-01-13. The listed applicant is Stryker Craniomaxillofacial. The 510(k) number is K232350.

When did Stryker Facial iD System receive FDA 510(k) clearance?

Stryker Facial iD System received FDA 510(k) clearance on 2024-01-13, under 510(k) number K232350.

Who is the listed applicant for Stryker Facial iD System?

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

What is the FDA product code for Stryker Facial iD System?

The FDA product code for Stryker Facial iD 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.

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