FDA 510(k)

Vertex Hip Fracture Nailing System

Номер K: K233910 · 2024-04-04

ЗаявительOrthoxel Dac

Дата решения2024-04-04

Код продуктаHSB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Vertex Hip Fracture Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Orthoxel Dac. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233910. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vertex Hip Fracture Nailing System?

Vertex Hip Fracture Nailing System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Orthoxel Dac. The 510(k) number is K233910.

When did Vertex Hip Fracture Nailing System receive FDA 510(k) clearance?

Vertex Hip Fracture Nailing System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233910.

Who is the listed applicant for Vertex Hip Fracture Nailing System?

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

What is the FDA product code for Vertex Hip Fracture Nailing System?

The FDA product code for Vertex Hip Fracture Nailing System is HSB.

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: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Официальный источник

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