Chrysalis Intelligence · Sponsors · Aurora Spine

Aurora Spine

Carlsbad, CA, US · 6 510(k) clearances

Total clearances
6
2021-03-23 → 2025-03-24
Last 12 months
0
Product codes
6
Most recent
2025-03-24
Name variants in FDA filings: Aurora Spine, Inc. / Aurora Spine
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MRW System, Facet Screw Spinal Device Unclassified Unknown 1 2025-03-24
OUR Sacroiliac Joint Fixation Class II Orthopedic 1 2022-10-03
PEK Spinous Process Plate Class II Orthopedic 1 2022-07-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 1 2022-05-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2021-08-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2021-03-23
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-03-24 K243865 AERO MIS Facet Fusion System MRW Unclassified Unknown
2022-10-03 K221047 SILO TFX MIS Sacroiliac Joint Fixation System OUR Class II Orthopedic
2022-07-08 K221399 ZIP™ MIS Interspinous Fusion System PEK Class II Orthopedic
2022-05-27 K220610 SOLO-L OVD Class II Orthopedic
2021-08-02 K210521 DEXA-C Cervical Interbody System ODP Class II Orthopedic
2021-03-23 K210325 APOLLO Anterior Cervical Plate (ACP) System KWQ Class II Orthopedic