510(k) K092044

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE by Orthocor Medical — Product Code ILX

K092044 is an FDA 510(k) premarket notification submitted by Orthocor Medical for the device "ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE". The FDA issued a decision of Substantially Equivalent on December 18, 2009. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Orthocor Medical has at least 2 other 510(k) clearances on record.