510(k) K930771

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM by Orthomet, Inc. — Product Code JDI

K930771 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM". The FDA issued a decision of SN on November 30, 1994. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Orthomet, Inc. has at least 10 other 510(k) clearances on record.