510(k) K802342

PROXIMAL INTERPHALANGEAL JOINT IMPLANT by Sutter Biomedical, Inc. — Product Code JDI

K802342 is an FDA 510(k) premarket notification submitted by Sutter Biomedical, Inc. for the device "PROXIMAL INTERPHALANGEAL JOINT IMPLANT". The FDA issued a decision of Substantially Equivalent on October 14, 1981. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Sutter Biomedical, Inc. has at least 10 other 510(k) clearances on record.