510(k) K213785

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid by Limacorporate — Product Code KWS

K213785 is an FDA 510(k) premarket notification submitted by Limacorporate for the device "SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Limacorporate has at least 3 other 510(k) clearances on record.