Vertebron, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Vertebron, Inc.” (first 2004, latest 2008), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Vertebron, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | KWQ | 2008-07-03 | 29 |
| K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | MNI | 2008-07-02 | 26 |
| K073502 | VERTEBRON VBR SYSTEM | MQP | 2008-03-24 | 102 |
| K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | NKB | 2007-06-13 | 27 |
| K062110 | VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2006-08-16 | 23 |
| K051815 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2005-10-17 | 104 |
| K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM | KWP | 2005-09-07 | 72 |
| K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | MNH | 2005-02-01 | 78 |
| K043181 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2004-12-17 | 30 |
| K040003 | VERTEBRON SCP CERVICAL PLATE SYSTEM | KWQ | 2004-03-26 | 84 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vertebron, 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 Vertebron, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Vertebron, Inc.” (first 2004, latest 2008), across 6 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 Vertebron, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vertebron, Inc. is 72 days.
Which FDA product codes appear under Vertebron, Inc.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5); MNI (Orthosis, Spinal Pedicle Fixation, 2); KWP (Appliance, Fixation, Spinal Interlaminal, 1).
Next steps
- See all 11 Vertebron, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Vertebron, 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.