Cleared Traditional

MONTAGE Settable, Resorbable Bone Putty

K221933 · Orthocon, Inc. · Neurology
Jan 2023
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K221933 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty, a Methyl Methacrylate For Cranioplasty (Class II — Special Controls, product code GXP), submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on January 13, 2023, 196 days after receiving the submission on July 1, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K221933 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2022
Decision Date January 13, 2023
Days to Decision 196 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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