Cleared Traditional

MONTAGE-QS Settable, Resorbable Hemostatic Bone

K191140 · Orthocon, Inc. · General & Plastic Surgery
Jul 2019
Decision
79d
Days
—
Risk

About This 510(k) Submission

K191140 is an FDA 510(k) clearance for the MONTAGE-QS Settable, Resorbable Hemostatic Bone, 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 review panel.

Submission Details

510(k) Number K191140 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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