Data / Medical devices / United States / Xerxes Arthropedix
Xerxes Arthropedix: FDA-registered device maker in Naples, FL, United States, 1 510(k) clearance
Xerxes Arthropedix is registered with the FDA (registration 3030338875) in Naples, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030338875
- Address
- 181 Eugenia Dr, Naples, FL, United States, 34108
- Owner or operator
- Xerxes Arthropedix (10086998)
- Roles
- Specification developer
- First device listed
- January 12, 2024
- Registered through
- 2026
- Brand names listed
- Xerxes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 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 |
|---|---|---|---|---|---|---|
| June 15, 2023 | K231109 | Xerxes Hip Stem | LZO | Substantially Equivalent | Xerxes Arthopedix, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Updated June 15, 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.