510(k) K053094

ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 by Advanced Bio-Surfaces, Inc. — Product Code HSH

K053094 is an FDA 510(k) premarket notification submitted by Advanced Bio-Surfaces, Inc. for the device "ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056". The FDA issued a decision of Substantially Equivalent on February 6, 2006. The device falls under product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)), a Class II device regulated under 21 CFR 888.3590. Advanced Bio-Surfaces, Inc. has at least 1 other 510(k) clearance on record.