510(k) K141377

BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD by Merete Medical GmbH — Product Code LZO

K141377 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD". The FDA issued a decision of Substantially Equivalent on November 21, 2014. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Merete Medical GmbH has at least 10 other 510(k) clearances on record.