Cleared Traditional

Fusion Craniofacial Implant; Fusion Skull Implant

K250334 · Kelyniam Global, Inc. · Neurology
Jul 2025
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K250334 is an FDA 510(k) clearance for the Fusion Craniofacial Implant; Fusion Skull Implant, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Kelyniam Global, Inc. (Canton, US). The FDA issued a Cleared decision on July 25, 2025, 170 days after receiving the submission on February 5, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K250334 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2025
Decision Date July 25, 2025
Days to Decision 170 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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