510(k) K022779

OTI UNICONDULAR INTERPOSITIONAL SPACER by Osteoimplant Technology, Inc. — Product Code HSH

K022779 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "OTI UNICONDULAR INTERPOSITIONAL SPACER". The FDA issued a decision of Substantially Equivalent on November 20, 2002. The device falls under product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)), a Class II device regulated under 21 CFR 888.3590. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.