FDA 510(k)

OmniPore DUROMAX Surgical Implants

Номер K: K180249 · 2018-10-11

ЗаявительMatrix Surgical Holdings, LLC/Matrix Surgical USA

Дата решения2018-10-11

Код продуктаJEY

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

OmniPore DUROMAX Surgical Implants is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K180249. 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 OmniPore DUROMAX Surgical Implants?

OmniPore DUROMAX Surgical Implants is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. The 510(k) number is K180249.

When did OmniPore DUROMAX Surgical Implants receive FDA 510(k) clearance?

OmniPore DUROMAX Surgical Implants received FDA 510(k) clearance on 2018-10-11, under 510(k) number K180249.

Who is the listed applicant for OmniPore DUROMAX Surgical Implants?

The FDA 510(k) record lists Matrix Surgical Holdings, LLC/Matrix Surgical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniPore DUROMAX Surgical Implants?

The FDA product code for OmniPore DUROMAX Surgical Implants 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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