510(k) K921836

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD by Orthomet, Inc. — Product Code LZO

K921836 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on November 6, 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. Orthomet, Inc. has at least 10 other 510(k) clearances on record.