FDA 510(k) Applications Submitted by BRIAN SMEKAL

FDA 510(k) Number Submission Date Device Name Applicant
K130120 01/17/2013 EXTREMITY MEDICAL IP FUSION SYSTEM EXTREMITY MEDICAL, LLC
K150166 01/26/2015 Extremity Medical Suture Anchor EXTREMITY MEDICAL LLC
K160191 01/27/2016 Align Anterior Ankle Fusion Plate Extremity Medical, LLC
K150309 02/09/2015 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL, LLC
K180808 03/28/2018 Omni Foot Plating System Extremity Medical, LLC
K171018 04/05/2017 Axis Charcot Fixation System, 4.5 to 8.5mm Screw System Extremity Medical, LLC.
K181067 04/23/2018 AlignX Ankle Fusion System Extremity Medical, LLC
K172260 07/27/2017 Omni Foot Plating System Extremity Medical, LLC.
K152710 09/21/2015 HammerFiX Device EXTREMITY MEDICAL, LLC
K062876 09/26/2006 PRIMACONNEX CERAMIC ABUTMENTS LIFECORE BIOMEDICAL, INC.
K133636 11/26/2013 EXTREMITY MEDICAL HAMMERTOE DEVICE EXTREMITY MEDICAL, LLC.
K143402 11/28/2014 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL LLC
K053643 12/30/2005 STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 LIFECORE BIOMEDICAL, INC.


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