Cleared Traditional

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

K220357 · Medcad · Neurology
Aug 2022
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K220357 is an FDA 510(k) clearance for the MedCAD AccuShape Titanium Patient-Specific Cranial Implant, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on August 26, 2022, 199 days after receiving the submission on February 8, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K220357 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2022
Decision Date August 26, 2022
Days to Decision 199 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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