Cleared Traditional

MONTAGE-QS Settable, Resorbable Bone Putty

K231475 · Orthocon, Inc. · Neurology
Oct 2023
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K231475 is an FDA 510(k) clearance for the MONTAGE-QS Settable, Resorbable 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 October 12, 2023, 143 days after receiving the submission on May 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K231475 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2023
Decision Date October 12, 2023
Days to Decision 143 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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