FDA 510(k)

Meduloc Intramedullary Fracture Fixation (IFF) System

Numéro K : K250316 · 2025-10-29

Date de décision2025-10-29

Code produitJDW

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : JDW)

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Source officielle

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