Vertiflex, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vertiflex, Inc.” (first 2008, latest 2012), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 98 |
| 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 |
|---|---|---|---|
| HRX | Arthroscope | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Vertiflex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122509 | VERTIFLEX SPINOUS PROCESS FIXATION PLATE | KWP | 2012-12-17 | 122 |
| K122662 | VERTIFLEX DIRECT DECOMPRESSION SYSTEM | HRX | 2012-11-13 | 74 |
| K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM | MAX | 2008-09-16 | 36 |
| K073143 | MODIFIED VERTIFLEX SPINAL SCREW SYSTEM | MNI | 2008-04-07 | 152 |
| K073245 | EXTENDED VERTIFLEX SPINAL SCREW SYSTEM | NKB | 2008-02-15 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Vertiflex, 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.
Device clinical trials
An industry sponsor named Vertiflex, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02079038: The STEPS - Totalis™ Trial (Completed, started 2014-05)
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.
- Vertiflex (Tm), Incorporated (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vertiflex, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Vertiflex, Inc.” (first 2008, latest 2012), across 5 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 Vertiflex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vertiflex, Inc. is 88 days.
Which FDA product codes appear under Vertiflex, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 1); KWP (Appliance, Fixation, Spinal Interlaminal, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 5 Vertiflex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Vertiflex, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.