Data / Medical devices / United States / Palaxa Precision LLC
Palaxa Precision LLC: FDA-registered device maker in Newport, MN, United States, 1 510(k) clearance
Palaxa Precision LLC is registered with the FDA (registration 3043841530) in Newport, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043841530
- Address
- 2104 Hastings Ave Ste 270, Newport, MN, United States, 55055
- Owner or operator
- Palaxa Precision LLC (10094830)
- Roles
- Specification developer
- First device listed
- March 10, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | 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 |
|---|---|---|---|---|---|---|
| April 28, 2022 | K202691 | Ortholock Anchorage Devices | OAT | Substantially Equivalent | Craniofacial Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Implant, Endosseous, Orthodontic
- All makers of Accessories, Implant, Dental, Endosseous
Updated April 28, 2022. 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.