510(k) K915190

PERFECTA TOTAL HIP SYSTEM, HA COATED by Orthomet, Inc. — Product Code MEH

K915190 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "PERFECTA TOTAL HIP SYSTEM, HA COATED". The FDA issued a decision of Substantially Equivalent on December 24, 1992. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Orthomet, Inc. has at least 10 other 510(k) clearances on record.