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Aurora Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243865AERO MIS Facet Fusion SystemMarch 24, 2025
K221047SILO TFX MIS Sacroiliac Joint Fixation SystemOctober 3, 2022
K221399ZIP™ MIS Interspinous Fusion SystemJuly 8, 2022
K220610SOLO-LMay 27, 2022
K210521DEXA-C Cervical Interbody SystemAugust 2, 2021
K210325APOLLO Anterior Cervical Plate (ACP) SystemMarch 23, 2021
K141317ZIP MIS INTERSPINOUS FUSION SYSTEMNovember 17, 2014
K140715ZIP MIS INTERSPINOUS FUSION SYSTEMApril 17, 2014
K133967INTERBODY CAGE SYSTEMJanuary 31, 2014
K133091ZIP MIS INTERSPINOUS FUSION SYSTEMNovember 27, 2013