Cleared Traditional

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

K231386 · Orthocon, Inc. · Orthopedic
Jul 2023
Decision
60d
Days
—
Risk

About This 510(k) Submission

K231386 is an FDA 510(k) clearance for the Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste, a Wax, Bone, submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on July 11, 2023, 60 days after receiving the submission on May 12, 2023. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K231386 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2023
Decision Date July 11, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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