Vilex IN Tennessee, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Vilex IN Tennessee, Inc.” (first 2014, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 77 days, against 112 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 |
|---|---|---|
| 2014 | 1 | 55 |
| 2015 | 2 | 217 |
| 2016 | 1 | 259 |
| 2017 | 1 | 63 |
| 2018 | 0 | — |
| 2019 | 2 | 82 |
| 2020 | 0 | — |
| 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 Vilex IN Tennessee, Inc. took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Vilex IN Tennessee, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191289 | Bone Screw Line Addition | HWC | 2019-07-29 | 77 |
| K190543 | Cannulated Hemi Implant | KWD | 2019-05-31 | 88 |
| K163487 | Ultima HA Coated Half Pins and Wire | JDW | 2017-02-13 | 63 |
| K151881 | X-Fix Line Additions | KTT | 2016-03-24 | 259 |
| K150211 | EzFuze Implant System | HWC | 2015-11-10 | 284 |
| K151456 | Small Bone Nail Implant | HSB | 2015-10-29 | 150 |
| K141937 | TRIDENT FUSION IMPLANT | HWC | 2014-09-10 | 55 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-04-22.
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.
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.
- Vilex, LLC (30 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vilex IN Tennessee, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Vilex IN Tennessee, Inc.” (first 2014, latest 2019), 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 Vilex IN Tennessee, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vilex IN Tennessee, Inc. is 88 days. Since 2017: 77 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vilex IN Tennessee, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 1); JDW (Pin, Fixation, Threaded, 1).
Next steps
- See all 7 Vilex IN Tennessee, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Vilex IN Tennessee, 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.