Frontier Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Frontier Medical Devices, Inc.” (first 2012, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 108 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 | 1 | 412 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 3 | 108 |
| 2016 | 1 | 65 |
| 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Frontier Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | JDQ | 2016-01-13 | 65 |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | JDQ | 2015-10-30 | 112 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | JDQ | 2015-08-20 | 92 |
| K143228 | Ancora LLC Interbody Fusion Device | OVD | 2015-02-26 | 108 |
| K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | OVD | 2012-11-01 | 412 |
Recalls
openFDA lists no recalls under a recalling firm named Frontier Medical Devices, 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.
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.
- Frontier Novelty, Inc. (4 510(k)s)
- Frontier Products (4 510(k)s)
- Frontier Devices, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Frontier Medical Devices, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Frontier Medical Devices, Inc.” (first 2012, latest 2016), across 2 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 Frontier Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Frontier Medical Devices, Inc. is 108 days.
Which FDA product codes appear under Frontier Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are JDQ (Cerclage, Fixation, 3); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2).
Next steps
- See all 5 Frontier Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDQ, Frontier Medical Devices, 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.