510(k) K082844

BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE by Encore Medical L.P. — Product Code LZO

K082844 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE". The FDA issued a decision of Substantially Equivalent on Nov 25, 2008. 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. Encore Medical L.P. has 81 other 510(k) clearances on record.