Cleared Special

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

K243526 · Orthocon, Inc. · Orthopedic

Dec 2024

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K243526 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic 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 December 5, 2024, 21 days after receiving the submission on November 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K243526 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2024
Decision Date	December 05, 2024
Days to Decision	21 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF