Vertebral Technologies, Inc.: FDA clearances and approvals
Vertebral Technologies, Inc. has 7 FDA 510(k) clearances (first 2008, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time: 56 days. openFDA lists 1 product recall by a recalling firm named Vertebral Technologies, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 97 |
| 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 | 7 | 7 |
Review panels
- Orthopedic (7)
Most recent Vertebral Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131540 | INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE | MAX | 2013-09-03 | 97 |
| K110226 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | MAX | 2011-05-27 | 122 |
| K110045 | INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE | MAX | 2011-02-03 | 28 |
| K102277 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | MAX | 2010-10-06 | 56 |
| K093675 | INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 | MAX | 2009-12-23 | 26 |
| K091988 | MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 | MAX | 2009-07-30 | 28 |
| K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE | MAX | 2008-06-10 | 92 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-01-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vertebral Technologies, Inc. have?
Vertebral Technologies, Inc. has 7 FDA 510(k) clearances (first 2008, latest 2013), across 1 product code in 1 review panel.
How long does FDA take to clear Vertebral Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vertebral Technologies, Inc.'s cleared 510(k)s is 56 days.
What devices does Vertebral Technologies, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7).
Has Vertebral Technologies, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Vertebral Technologies, Inc; the most recent began 2017-01-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Vertebral Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Vertebral Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.