510(k) K100264

T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 by Bionix Development Corp. — Product Code IYE

K100264 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060". The FDA issued a decision of Substantially Equivalent on April 9, 2010. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Bionix Development Corp. has at least 10 other 510(k) clearances on record.