Cleared Traditional

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

K220315 · Orthocon, Inc. · Orthopedic
Mar 2022
Decision
36d
Days
—
Risk

About This 510(k) Submission

K220315 is an FDA 510(k) clearance for the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty, 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 review panel.

Submission Details

510(k) Number K220315 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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