510(k) K973307

S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD by Johnson & Johnson Professionals, Inc. — Product Code LZO

K973307 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD". The FDA issued a decision of SN on November 20, 1997. 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. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.