FDA 510(k)

Meduloc Intramedullary Fracture Fixation (IFF) System

Номер K: K250316 · 2025-10-29

ЗаявительMeduloc, LLC

Дата решения2025-10-29

Код продуктаJDW

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Meduloc Intramedullary Fracture Fixation (IFF) System is the device name listed in this FDA 510(k) record. The listed applicant is Meduloc, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K250316. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Meduloc Intramedullary Fracture Fixation (IFF) System?

Meduloc Intramedullary Fracture Fixation (IFF) System is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Meduloc, LLC. The 510(k) number is K250316.

When did Meduloc Intramedullary Fracture Fixation (IFF) System receive FDA 510(k) clearance?

Meduloc Intramedullary Fracture Fixation (IFF) System received FDA 510(k) clearance on 2025-10-29, under 510(k) number K250316.

Who is the listed applicant for Meduloc Intramedullary Fracture Fixation (IFF) System?

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

What is the FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System?

The FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System is JDW.

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: JDW)

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH K210784Extended HA Half PinsSmith & Nephew, Inc.

Официальный источник

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