510(k) K922847

PERFECTA TOTAL HIP SYSTEM by Orthomet, Inc. — Product Code JDI

K922847 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "PERFECTA TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 6, 1993. 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.