Data / Medical devices / United States / Dev4
Dev4: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances
Dev4 is registered with the FDA (registration 3029894043) in Houston, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029894043
- Address
- 1002 Gemini st. suite 129, Houston, TX, United States, 77058
- Owner or operator
- Dev4 (10089195)
- Roles
- Specification developer
- First device listed
- November 14, 2023
- Registered through
- 2026
- Brand names listed
- Eleganz Fusion Screw System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2025 | K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | HWC | Substantially Equivalent | Dev4 | accessdata.fda.gov |
| June 13, 2025 | K250251 | Eleganz Fusion Screw System (Fusion Screw System) | HWC | Substantially Equivalent | Dev4 | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.