510(k) K884952

VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC by Protek, Inc. — Product Code LZO

K884952 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC". The FDA issued a decision of Substantially Equivalent on May 10, 1989. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Protek, Inc. has at least 10 other 510(k) clearances on record.