510(k) K823441

AUSTIN MODIFIED TOTAL OSSICULAR REPLACE by Treace Medical, Inc. — Product Code LBM

K823441 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "AUSTIN MODIFIED TOTAL OSSICULAR REPLACE". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code LBM (Porous Polyethylene Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.