510(k) K132908

TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT by Medtec, Inc. — Product Code IYE

K132908 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT". The FDA issued a decision of Substantially Equivalent on March 4, 2014. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medtec, Inc. has at least 10 other 510(k) clearances on record.