Cleared Traditional

K220315 - MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K220315 · Orthocon, Inc. · Orthopedic device

Mar 2022

Decision

36d

Days

—

Risk

K220315 is an FDA 510(k) clearance for the MONTAGE-XT 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 March 11, 2022, 36 days after receiving the submission on February 3, 2022.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K220315 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 2022
Decision Date	March 11, 2022
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF