510(k) K070928

CERAMIC BALL HEADS, 28, 32 AND 36 MM by Plus Orthopedics AG — Product Code LZO

K070928 is an FDA 510(k) premarket notification submitted by Plus Orthopedics AG for the device "CERAMIC BALL HEADS, 28, 32 AND 36 MM". The FDA issued a decision of Substantially Equivalent on August 1, 2007. 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. Plus Orthopedics AG has at least 10 other 510(k) clearances on record.