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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