Cleared Traditional

Montage Flowable Settable, Resorbable Bone Paste

K232771 · Orthocon, Inc. · Neurology
Feb 2024
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K232771 is an FDA 510(k) clearance for the Montage Flowable Settable, Resorbable Bone Paste, 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 February 16, 2024, 158 days after receiving the submission on September 11, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K232771 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2023
Decision Date February 16, 2024
Days to Decision 158 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