Cleared Traditional

Synthes Patient Specific Implants

K243715 · Synthes GmbH · Neurology
Nov 2025
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K243715 is an FDA 510(k) clearance for the Synthes Patient Specific Implants, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on November 12, 2025, 345 days after receiving the submission on December 2, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K243715 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2024
Decision Date November 12, 2025
Days to Decision 345 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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