# Aurora Spine, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 10 (2013–2025): 10 510(k) clearances
- Names in FDA's records: Aurora Spine, Inc. (7); Aurora Spine (3)
- Product codes: PEK (4), KWQ (1), OVD (1), MAX (1), ODP (1), OUR (1), MRW (1)
- 510(k) review time since 2016: median 91 days, against 127 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 19 (6 its own); citations of its devices by later devices: 18 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lanx, Inc.: 1 (https://510kreport.com/company/lanx)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)
- Lespine Innovations, LLC: 1 (https://510kreport.com/company/lespine-innovations)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Osteomed Implantes, Ltda: 1 (https://510kreport.com/company/osteomed-implantes)
- Acuity Surgical Devices, LLC: 1 (https://510kreport.com/company/acuity-surgical-devices)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)
- Intuitive Spine, LLC: 1 (https://510kreport.com/company/intuitive-spine)

## Firms that cite its devices most
- Acuity Surgical Devices, LLC: 2 (https://510kreport.com/company/acuity-surgical-devices)
- Integrity Spine: 1 (https://510kreport.com/company/integrity-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Neurostructures, Inc.: 1 (https://510kreport.com/company/neurostructures)
- Sail Fusion, LLC: 1 (https://510kreport.com/company/sail-fusion)
- Camber Spine Technologies: 1 (https://510kreport.com/company/camber-spine-technologies)
- Spinal Simplicity, LLC: 1 (https://510kreport.com/company/spinal-simplicity)
- SurGenTec, LLC: 1 (https://510kreport.com/company/surgentec)

## Its most-cited devices
- K133967: Interbody Cage System (2014), cited by 7
- K133091: Zip Mis Interspinous Fusion System (2013), cited by 4
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System (2022), cited by 3
- K141317: Zip Mis Interspinous Fusion System (2014), cited by 2
- K140715: Zip Mis Interspinous Fusion System (2014), cited by 2

## Recent decisions
- K243865: AERO MIS Facet Fusion System (Mar 24, 2025)
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System (Oct 3, 2022)
- K221399: ZIP™ MIS Interspinous Fusion System (Jul 8, 2022)
- K220610: SOLO-L (May 27, 2022)
- K210521: DEXA-C Cervical Interbody System (Aug 2, 2021)
- K210325: APOLLO Anterior Cervical Plate (ACP) System (Mar 23, 2021)
- K141317: Zip Mis Interspinous Fusion System (Nov 17, 2014)
- K140715: Zip Mis Interspinous Fusion System (Apr 17, 2014)

Source page: https://510kreport.com/company/aurora-spine