510(k) K800530

SCHLEIN TRI-SURFACE ANKLE by Orthopedic Equipment Co., Inc. — Product Code HSN

K800530 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "SCHLEIN TRI-SURFACE ANKLE". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.