FDA 510(k)

Active Intramedullary (AIM) Тибиальный штифт системы

Номер K: K252025 · 2026-03-04

Дата решения2026-03-04

Код продуктаHSB

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Active Intramedullary (AIM) Tibial Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Satori Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K252025. 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 Active Intramedullary (AIM) Tibial Nail System?

Active Intramedullary (AIM) Tibial Nail System is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Satori Orthopaedics, Inc.. The 510(k) number is K252025.

When did Active Intramedullary (AIM) Tibial Nail System receive FDA 510(k) clearance?

Active Intramedullary (AIM) Tibial Nail System received FDA 510(k) clearance on 2026-03-04, under 510(k) number K252025.

Who is the listed applicant for Active Intramedullary (AIM) Tibial Nail System?

The FDA 510(k) record lists Satori Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Active Intramedullary (AIM) Tibial Nail System?

The FDA product code for Active Intramedullary (AIM) Tibial Nail 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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