Data / Medical devices / United States / Aurora Spine, Inc.
Aurora Spine, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 11 510(k) clearances
Aurora Spine, Inc. is registered with the FDA (registration 3010326971) in Carlsbad, CA, United States. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010326971
- Address
- 1930 Palomar Point Way Suite #103, Carlsbad, CA, United States, 92008
- Owner or operator
- Aurora Spine (10045511)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 25, 2013
- Registered through
- 2026
- Brand names listed
- AFFINITY MIS Interbody Fusion System, APOLLO Anterior Cervical Plate (ACP) System, DEXA SOLO-L Standalone Anterior Fusion System, DEXA-C Cervical Interbody System, DISCOVERY MIS Interbody Fusion System, ECHO MIS Interbody Fusion System, ECHO XL MIS Interbody Fusion System, EOS MIS Interbody Fusion System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2022 | K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| July 8, 2022 | K221399 | ZIP MIS Interspinous Fusion System | PEK | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| May 27, 2022 | K220610 | SOLO-L | OVD | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| August 2, 2021 | K210521 | DEXA-C Cervical Interbody System | ODP | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| March 23, 2021 | K210325 | APOLLO Anterior Cervical Plate (ACP) System | KWQ | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| November 17, 2014 | K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | Substantially Equivalent | Aurora Spine, Inc. | accessdata.fda.gov |
| January 31, 2014 | K133967 | INTERBODY CAGE SYSTEM | MAX | Substantially Equivalent | Aurora Spine | accessdata.fda.gov |
| November 27, 2013 | K133091 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | Substantially Equivalent | Aurora Spine | accessdata.fda.gov |
| September 12, 2011 | K111484 | DISCOVERY | ODP | Substantially Equivalent | Intuitive Spine, LLC | accessdata.fda.gov |
| July 6, 2007 | K071743 | PILLAR PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | The 4th Column, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Sacroiliac Joint Fixation
- All makers of Spinous Process Plate
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Orthosis, Spinal Pedicle Fixation
Updated October 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.