Cleared Traditional

Montage-QS Settable, Resorbable Bone Putty

K231903 · Orthocon, Inc. · Orthopedic
Aug 2023
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K231903 is an FDA 510(k) clearance for the Montage-QS Settable, Resorbable Bone Putty, 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 August 25, 2023, 58 days after receiving the submission on June 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231903 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date August 25, 2023
Days to Decision 58 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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