510(k) K903234

F-19 TOTAL HIP PROSTHESIS by Med-Tek Corp. — Product Code JDI

K903234 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "F-19 TOTAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 10, 1990. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Med-Tek Corp. has at least 10 other 510(k) clearances on record.