Aurora Spine, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Aurora Spine, Inc.” (first 2013, latest 2025), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 91 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 58 |
| 2014 | 3 | 38 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 104 |
| 2022 | 3 | 85 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 97 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aurora Spine, Inc. took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PEK | Spinous Process Plate | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Aurora Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243865 | AERO MIS Facet Fusion System | MRW | 2025-03-24 | 97 |
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | OUR | 2022-10-03 | 178 |
| K221399 | ZIP MIS Interspinous Fusion System | PEK | 2022-07-08 | 56 |
| K220610 | SOLO-L | OVD | 2022-05-27 | 85 |
| K210521 | DEXA-C Cervical Interbody System | ODP | 2021-08-02 | 160 |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | KWQ | 2021-03-23 | 47 |
| K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | 2014-11-17 | 181 |
| K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | 2014-04-17 | 27 |
| K133967 | INTERBODY CAGE SYSTEM | MAX | 2014-01-31 | 38 |
| K133091 | ZIP MIS INTERSPINOUS FUSION SYSTEM | PEK | 2013-11-27 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Aurora Spine, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aurora Imaging Technology, Inc. (7 510(k)s)
- Aurora Technology, Inc. (1 510(k)s)
- Aurora Technology Development, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aurora Spine, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Aurora Spine, Inc.” (first 2013, latest 2025), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aurora Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aurora Spine, Inc. is 72 days. Since 2017: 91 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aurora Spine, Inc.?
The most frequent FDA product codes under this applicant name are PEK (Spinous Process Plate, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 10 Aurora Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PEK, Aurora Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.