Data / Medical devices / United States / Relja Innovations, Inc
Relja Innovations, Inc: FDA-registered device maker in Wauwatosa, WI, United States, 1 510(k) clearance
Relja Innovations, Inc is registered with the FDA (registration 3025114181) in Wauwatosa, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025114181
- Address
- 11220 W. Burleigh St M102, Wauwatosa, WI, United States, 53222
- Owner or operator
- RELJA Innovations Inc (10085827)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 17, 2022
- Registered through
- 2026
- Brand names listed
- MIS Precision Chevron Bunion System, RELJA Lapidus Screw Kit, Reduction Clamp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Compression | HWN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 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 |
|---|---|---|---|---|---|---|
| January 31, 2022 | K211628 | MIS Precision Chevron Bunion System | HWC | Substantially Equivalent | Relja Innovations, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 31, 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.