Cleared Special

MONTAGE Settable, Resorbable Hemostatic Bone Putty

K152005 · Orthocon, Inc. · General & Plastic Surgery
Oct 2015
Decision
87d
Days
—
Risk

About This 510(k) Submission

K152005 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Hemostatic Bone Putty, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on October 15, 2015, 87 days after receiving the submission on July 20, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K152005 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2015
Decision Date October 15, 2015
Days to Decision 87 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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