Cleared Special

Montage- XT Settable, Resorbable Hemostatic Bone Putty

K232998 · Orthocon, Inc. · Orthopedic
Oct 2023
Decision
20d
Days
—
Risk

About This 510(k) Submission

K232998 is an FDA 510(k) clearance for the Montage- XT Settable, Resorbable Hemostatic Bone Putty, a Wax, Bone, submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on October 12, 2023, 20 days after receiving the submission on September 22, 2023. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K232998 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date October 12, 2023
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class —

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