510(k) K152312

RECON system-V-TEK-IVP Plates and Screws by Normed Medizin-Technik GmbH — Product Code HRS

K152312 is an FDA 510(k) premarket notification submitted by Normed Medizin-Technik GmbH for the device "RECON system-V-TEK-IVP Plates and Screws". The FDA issued a decision of Substantially Equivalent on Oct 30, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Normed Medizin-Technik GmbH has 8 other 510(k) clearances on record.