510(k) K915309

KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL by Kinamed, Inc. — Product Code LZO

K915309 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL". The FDA issued a decision of Substantially Equivalent on February 19, 1992. 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. Kinamed, Inc. has at least 10 other 510(k) clearances on record.