Cleared Traditional

K191140 - MONTAGE-QS Settable, Resorbable Hemostatic Bone (FDA 510(k) Clearance)

K191140 · Orthocon, Inc. · General & Plastic Surgery device

Jul 2019

Decision

79d

Days

—

Risk

K191140 is an FDA 510(k) clearance for the MONTAGE-QS Settable, Resorbable Hemostatic Bone. This device is classified as a Wax, Bone.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on July 18, 2019, 79 days after receiving the submission on April 30, 2019.

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

Submission Details

510(k) Number	K191140 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 2019
Decision Date	July 18, 2019
Days to Decision	79 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF