Genesis Fracture Care, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Genesis Fracture Care, Inc.” (first 2014, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|
| 2014 | 1 | 48 |
| 2015 | 2 | 78 |
| 2016 | 1 | 46 |
| 2017 | 1 | 174 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 Genesis Fracture Care, Inc. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Genesis Fracture Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171293 | G3 Active Plate® Miniature System | HRS | 2017-10-23 | 174 |
| K160633 | G3(TM) Active Plate(R) Small Fragment System | HRS | 2016-04-22 | 46 |
| K152242 | G3¿ Active Plate® Large Fragment System | HRS | 2015-11-24 | 106 |
| K150649 | G3 Active Plate Large Fragment System | HRS | 2015-04-30 | 49 |
| K142938 | G3 Active Plate Large Fragment System | HRS | 2014-11-26 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Genesis Fracture Care, 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.
- Genesis Industries, Inc. (17 510(k)s)
- Genesis Biosystems, Inc. (4 510(k)s)
- Genesis Labs, Inc. (3 510(k)s)
- Genesis Digital Imaging, Inc. (2 510(k)s)
- Genesis Medical LLC (2 510(k)s)
- Genesis Medical Interventional, Inc. (2 510(k)s)
- Genesis Orthopedics, Inc. (2 510(k)s)
- Genesis Software Innovations (2 510(k)s)
- Genesis Air, Inc. (1 510(k)s)
- Genesis Bps, LLC (1 510(k)s)
- Genesis Diagnostics , Ltd. (1 510(k)s)
- Genesis Health Light Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genesis Fracture Care, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Genesis Fracture Care, Inc.” (first 2014, latest 2017), across 1 product code 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 Genesis Fracture Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genesis Fracture Care, Inc. is 49 days.
Which FDA product codes appear under Genesis Fracture Care, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 5).
Next steps
- See all 5 Genesis Fracture Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Genesis Fracture Care, 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.