Truemed Group, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Truemed Group, LLC” (first 2014, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 329 days. Since 2017 the median was 294 days, against 104 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 | 385 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 329 |
| 2018 | 1 | 180 |
| 2019 | 1 | 259 |
| 2020 | 0 | — |
| 2021 | 1 | 491 |
| 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 Truemed Group, LLC took a median 294 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Truemed Group, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200575 | TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM | HRS | 2021-07-09 | 491 |
| K182650 | Arzzt Distal Radius and Ulna System | HRS | 2019-06-10 | 259 |
| K172189 | Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt | HSB | 2018-01-16 | 180 |
| K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | HRS | 2017-08-03 | 329 |
| K133166 | INS HILDEN TIBIAL ARZZT | HSB | 2014-11-06 | 385 |
Recalls
openFDA lists no recalls under a recalling firm named Truemed Group, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Truemed Group, LLC?
FDA lists 5 510(k) clearances under the applicant name “Truemed Group, LLC” (first 2014, latest 2021), 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 Truemed Group, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Truemed Group, LLC is 329 days. Since 2017: 294 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Truemed Group, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 2).
Next steps
- See all 5 Truemed Group, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Truemed Group, LLC'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.