510(k) K884888

MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS by Protek, Inc. — Product Code JDI

K884888 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS". The FDA issued a decision of SN on December 29, 1988. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Protek, Inc. has at least 10 other 510(k) clearances on record.