510(k) K884789

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI by Protek, Inc. — Product Code KWL

K884789 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI". The FDA issued a decision of SN on February 8, 1989. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Protek, Inc. has at least 10 other 510(k) clearances on record.