Cleared Special

Montage Settable Bone Putty

K242050 · Orthocon, Inc. · Orthopedic
Jul 2024
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K242050 is an FDA 510(k) clearance for the Montage Settable 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 July 29, 2024, 17 days after receiving the submission on July 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K242050 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2024
Decision Date July 29, 2024
Days to Decision 17 days
Submission Type Special
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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