Cleared Traditional

Permatage Settable Bone Putty

K241027 · Orthocon, Inc. · Neurology
Sep 2024
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K241027 is an FDA 510(k) clearance for the Permatage Settable Bone Putty, a Methyl Methacrylate For Cranioplasty (Class II — Special Controls, product code GXP), submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on September 26, 2024, 164 days after receiving the submission on April 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K241027 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2024
Decision Date September 26, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXP — Methyl Methacrylate For Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5300

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