Benvenue Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Benvenue Medical, Inc.” (first 2007, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 141 days. Since 2017 the median was 154 days, against 89 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 118 |
| 2015 | 0 | — |
| 2016 | 1 | 78 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 154 |
| 2020 | 2 | 188 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Benvenue Medical, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Benvenue Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201427 | Trivergent Spinal Fixation System | NKB | 2020-10-21 | 145 |
| K193172 | Luna XD Ti Interbody Fusion System | MAX | 2020-07-02 | 230 |
| K183560 | Luna 3D GEN2 Interbody Fusion System | MAX | 2019-05-23 | 154 |
| K162431 | Luna 3D Interbody Fusion System | MAX | 2016-11-17 | 78 |
| K142023 | LUNA INTERBODY SYSTEM | MAX | 2014-11-20 | 118 |
| K141141 | KIVA VCF TREATMENT SYSTEM | NDN | 2014-08-14 | 104 |
| K132817 | KIVA VCF TREATMENT SYSTEM | NDN | 2014-01-24 | 137 |
| K070293 | BENVENUE VCF OSTEO COIL SYSTEM | OCJ | 2007-07-10 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Benvenue Medical, 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 Benvenue Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01123512: The Kiva® System as a Vertebral Augmentation Treatment (Completed, started 2010-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Benvenue Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Benvenue Medical, Inc.” (first 2007, latest 2020), across 4 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 Benvenue Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Benvenue Medical, Inc. is 141 days. Since 2017: 154 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Benvenue Medical, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); NDN (Cement, Bone, Vertebroplasty, 2); NKB (Thoracolumbosacral Pedicle Screw System, 1).
Next steps
- See all 8 Benvenue Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Benvenue Medical, 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.