510(k) K934729

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED by Implantology Corp. — Product Code MEH

K934729 is an FDA 510(k) premarket notification submitted by Implantology Corp. for the device "UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED". The FDA issued a decision of SN on July 22, 1994. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Implantology Corp. has at least 8 other 510(k) clearances on record.