510(k) K131264

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS by Gebr. Brasseler GmbH & Co. KG — Product Code HWC

K131264 is an FDA 510(k) premarket notification submitted by Gebr. Brasseler GmbH & Co. KG for the device "KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS". The FDA issued a decision of Substantially Equivalent on July 26, 2013. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Gebr. Brasseler GmbH & Co. KG has at least 1 other 510(k) clearance on record.