FDA 510(k)

Корпектомные ячейки ArtFx (Espinax и Distractania Корпектомные ячейки)

Номер K: K211892 · 2022-10-06

Дата решения2022-10-06

Код продуктаMQP

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is the device name listed in this FDA 510(k) record. The listed applicant is Arftx Medical, LLC. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K211892. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Arftx Medical, LLC. The 510(k) number is K211892.

When did ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) receive FDA 510(k) clearance?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) received FDA 510(k) clearance on 2022-10-06, under 510(k) number K211892.

Who is the listed applicant for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

The FDA 510(k) record lists Arftx Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

The FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is MQP.

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: MQP)

K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group K261031POSEIDON STSignus Medinzintechnik GmbH K253158VyBrate™ VBR SystemVy Spine, LLC K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG K233359DOMINION Expandable Corpectomy SystemAstura Medical

Официальный источник

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