510(k) K923583

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

K923583 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "ORTHOMET PERFECTA TOTAL HIP SYSTEM". The FDA issued a decision of SN on December 7, 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.