Data / Medical devices / United States / New Paradigm Biomedical, LLC
New Paradigm Biomedical, LLC: FDA-registered device maker in Dorchester, MA, United States, 1 510(k) clearance
New Paradigm Biomedical, LLC is registered with the FDA (registration 3043355196) in Dorchester, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043355196
- Address
- 1452 Dorchester Ave Ste 4, Dorchester, MA, United States, 02122
- Owner or operator
- NPB Ortho (10095169)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 2, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | 2 | 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 |
|---|---|---|---|---|---|---|
| September 22, 2023 | K230067 | Para-Fix External Fixation System | LXT | Substantially Equivalent | New Paradigm Biomedical | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Updated September 22, 2023. 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.