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FDA 510(k) Applications Submitted by AURORA SPINE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140715
03/21/2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
AURORA SPINE, INC.
K141317
05/20/2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
AURORA SPINE, INC.
K210325
02/04/2021
APOLLO Anterior Cervical Plate (ACP) System
Aurora Spine, Inc.
K210521
02/23/2021
DEXA-C Cervical Interbody System
Aurora Spine, Inc.
K221047
04/08/2022
SILO TFX MIS Sacroiliac Joint Fixation System
Aurora Spine, Inc.
K221399
05/13/2022
ZIPÖ MIS Interspinous Fusion System
Aurora Spine, Inc.
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