510(k) K200045

MUTARS Cemented Femoral Stems by Implantcast GmbH — Product Code MEH

K200045 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "MUTARS Cemented Femoral Stems". The FDA issued a decision of Substantially Equivalent on October 16, 2020. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Implantcast GmbH has at least 10 other 510(k) clearances on record.