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FDA 510(k) Applications Submitted by Baui Biotech Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K161231
05/02/2016
FacilisÖ Spinal System
BAUI BIOTECH CO., LTD.
K191494
06/05/2019
FacilisÖ Spinal System
Baui Biotech Co., Ltd.
K182416
09/04/2018
NOVA Minimally Invasive System
BAUI Biotech CO., LTD.
K191353
05/21/2019
COMET Lumbar Interbody Fusion Cage
BAUI Biotech Co., Ltd.
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