Cleared Traditional

MONTAGE Settable, Resorbable Bone Putty

K222063 · Orthocon, Inc. · Orthopedic
Feb 2023
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K222063 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 3, 2023, 205 days after receiving the submission on July 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K222063 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2022
Decision Date February 03, 2023
Days to Decision 205 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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