Cleared Traditional

K231386 - Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (FDA 510(k) Clearance)

K231386 · Orthocon, Inc. · Orthopedic device

Jul 2023

Decision

60d

Days

—

Risk

K231386 is an FDA 510(k) clearance for the Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number	K231386 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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