Metagen, LLC: FDA clearances and approvals
Metagen, LLC has 5 FDA 510(k) clearances (first 1997, latest 1998), across 5 product codes in 1 review panel. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Metagen, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983976 | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM | JDQ | 1998-12-30 | 51 |
| K980609 | SEGMENTAL DEFECT REPLACEMENT SYSTEM | HSB | 1998-05-18 | 90 |
| K980020 | ACTIVELOCK MODULAR FEMORAL HIP SYSTEM | LPH | 1998-04-03 | 88 |
| K964003 | METAGEN ALL POLY ACETABULAR CUP SYSTEM | JDI | 1997-03-21 | 165 |
| K963700 | METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM | HRS | 1997-02-12 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Metagen, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Metagen, LLC have?
Metagen, LLC has 5 FDA 510(k) clearances (first 1997, latest 1998), across 5 product codes in 1 review panel.
How long does FDA take to clear Metagen, LLC's 510(k)s?
The median time from FDA receipt to decision across Metagen, LLC's cleared 510(k)s is 90 days.
What devices does Metagen, LLC make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1).
Has Metagen, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Metagen, LLC. Related entities may recall under other names.
Next steps
- See all 5 Metagen, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Metagen, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.