Cleared Special

K232998 - Montage- XT Settable, Resorbable Hemostatic Bone Putty (FDA 510(k) Clearance)

K232998 · Orthocon, Inc. · Orthopedic device

Oct 2023

Decision

20d

Days

—

Risk

K232998 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. (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 FDA review panel.

Submission Details

510(k) Number	K232998 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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