510(k) K901594

H.N. TOTAL HIP PROSTHESIS by Med-Tek Corp. — Product Code LWJ

K901594 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "H.N. TOTAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on August 3, 1990. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Med-Tek Corp. has at least 10 other 510(k) clearances on record.