510(k) K163397

SMR Hybrid Glenoid System by Lima Corporate S.P.A. — Product Code MBF

K163397 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "SMR Hybrid Glenoid System". The FDA issued a decision of Substantially Equivalent on June 29, 2017. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.