Cleared Special

K152005 - MONTAGE Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K152005 · Orthocon, Inc. · General & Plastic Surgery device

Oct 2015

Decision

87d

Days

—

Risk

K152005 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 October 15, 2015, 87 days after receiving the submission on July 20, 2015.

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

Submission Details

510(k) Number	K152005 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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