Data / Medical devices / United States / Meduloc
Meduloc: FDA-registered device maker in Del Mar, CA, United States, 1 510(k) clearance
Meduloc is registered with the FDA (registration 3042903229) in Del Mar, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042903229
- Address
- 2010 Jimmy Durante Blvd Ste 200, Del Mar, CA, United States, 92014
- Owner or operator
- Meduloc (10094686)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- Meduloc Intramedullary Fracture Fixation (IFF) System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, 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 29, 2025 | K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | JDW | Substantially Equivalent | Meduloc, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Pin, Fixation, Smooth
- All makers of Pin, Fixation, Threaded
- All makers of Screw, Fixation, Bone
- All makers of Tray, Surgical, Instrument
- All makers of Orthopedic Manual Surgical Instrument
Updated October 29, 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.