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FDA 510(k) Applications Submitted by Ji Yeong Seo
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210084
01/12/2021
SILKRO
Hironic Co., Ltd
K220416
02/14/2022
SwiftMR
AIRS Medical Inc.
K190425
02/22/2019
CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd.
K190708
03/19/2019
AccelFix Lumbar Interbody Fusion Cage System
L&K Biomed Co., Ltd.
K210999
04/02/2021
SwiftMR
AIRS Medical Inc.
K181380
05/24/2018
LnK Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd.
K181600
06/18/2018
PathLoc-SI Joint Fusion System
L&K BIOMED Co., Ltd.
K182544
09/17/2018
AccelFix Spinal Fixation System
L&K BioMed Co., Ltd.
K183117
11/09/2018
PathLoc-L MIS Spinal System
L&K Biomed Co., Ltd.
K183168
11/16/2018
OpenLoc-L Spinal Fixation System
L&K Biomed Co., Ltd.
K113186
10/28/2011
STERILE INSULIN PEN NEEDLE
SHINA CORP.
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