510(k) K843995

TF-II HIP PROSTHESIS by Dow Corning Corp. Healthcare Industries Materials — Product Code KWL

K843995 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "TF-II HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 23, 1985. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.