Cleared Traditional

K213418 - MONTAGE Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K213418 · Orthocon, Inc. · General & Plastic Surgery device

Aug 2023

Decision

679d

Days

—

Risk

K213418 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Hemostatic Bone Putty. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on August 30, 2023, 679 days after receiving the submission on October 20, 2021.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K213418 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 2021
Decision Date	August 30, 2023
Days to Decision	679 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF