510(k) K925536

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM by Orthomet, Inc. — Product Code KWY

K925536 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM". The FDA issued a decision of SN on January 7, 1994. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Orthomet, Inc. has at least 10 other 510(k) clearances on record.