Medical Device Manufacturer · US , Washington , DC

Aurora Spine, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2014

Recent clearances: SILO TFX MIS Sacroiliac Joint Fixation System, ZIP™ MIS Interspinous Fusion System, SOLO-L

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Aurora Spine, Inc. Orthopedic ✕

7 devices
1-7 of 7
Cleared Oct 03, 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · OUR
Orthopedic · 178d
Cleared Jul 08, 2022
ZIP™ MIS Interspinous Fusion System
K221399 · PEK
Orthopedic · 56d
Cleared May 27, 2022
SOLO-L
K220610 · OVD
Orthopedic · 85d
Cleared Aug 02, 2021
DEXA-C Cervical Interbody System
K210521 · ODP
Orthopedic · 160d
Cleared Mar 23, 2021
APOLLO Anterior Cervical Plate (ACP) System
K210325 · KWQ
Orthopedic · 47d
Cleared Nov 17, 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K141317 · PEK
Orthopedic · 181d
Cleared Apr 17, 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K140715 · PEK
Orthopedic · 27d
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