510(k) K223548

GMK Sphere & GMK SpheriKA Cementless by Medacta International S.A. — Product Code MBH

K223548 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK Sphere & GMK SpheriKA Cementless". The FDA issued a decision of Substantially Equivalent on Jan 20, 2023. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Medacta International S.A. has 207 other 510(k) clearances on record.