FDA 510(k) Applications Submitted by Sung Hee-Lee

FDA 510(k) Number Submission Date Device Name Applicant
K180729 03/20/2018 FaSet Fixation System Huvexel Co., Ltd
K162220 08/08/2016 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage DIO MEDICAL CO., LTD
K173080 09/29/2017 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) Huvexel Co., Ltd
K173099 09/29/2017 Fortis and Hana Anterior Cervical Plate System Huvexel Co., Ltd
K173131 09/29/2017 Rexious Spinal Fixation System Huvexel Co., Ltd
K173201 10/02/2017 UNITY Sacroiliac Joint Fixation System Huvexel Co., Ltd


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