Cleared Traditional

Montage Flowable Settable, Resorbable Bone Paste

K231270 · Orthocon, Inc. · Orthopedic
Sep 2023
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K231270 is an FDA 510(k) clearance for the Montage Flowable Settable, Resorbable Bone Paste, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on September 1, 2023, 122 days after receiving the submission on May 2, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231270 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2023
Decision Date September 01, 2023
Days to Decision 122 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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