Coalign Innovations, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Coalign Innovations, Inc.” (first 2011, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 39 days. 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 |
|---|---|---|
| 2012 | 1 | 28 |
| 2013 | 5 | 39 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 9 | 9 |
Review panels
- Orthopedic (9)
Most recent Coalign Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132505 | ACCULIF TL AND PL CAGE | MAX | 2013-09-12 | 31 |
| K131443 | COALIGN INNOVATIONS ACCULIF XL IBF CAGE | MAX | 2013-06-19 | 30 |
| K130194 | ACCULIF XL CAGE | MAX | 2013-04-03 | 65 |
| K123281 | ACCULIF TL-PEEK CAGE | MAX | 2013-01-23 | 93 |
| K123752 | ACCULIF TL AND PL CAGE | MAX | 2013-01-14 | 39 |
| K121683 | ACCULIF TL CAGE | MAX | 2012-07-05 | 28 |
| K113465 | ACCULIF TL CAGE | MAX | 2011-12-12 | 20 |
| K112095 | ACCULIF TL-PEEK IBF CAGE | MAX | 2011-12-01 | 132 |
| K110270 | ACCULIF CAGE | MAX | 2011-04-07 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Coalign Innovations, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Coalign Innovations, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Coalign Innovations, Inc.” (first 2011, latest 2013), across 1 product code 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 Coalign Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coalign Innovations, Inc. is 39 days.
Which FDA product codes appear under Coalign Innovations, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 9).
Next steps
- See all 9 Coalign Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Coalign Innovations, 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.