Data / Medical devices / Japan / KYOCERA Medical Corporation
KYOCERA Medical Corporation: FDA-registered device maker in Kyoto, Japan, 2 510(k) clearances
KYOCERA Medical Corporation is registered with the FDA (registration 3012425419) in Kyoto, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 5, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012425419
- FEI number
- 3010566635
- Address
- 6 Takeda Tobadono-cho, Fushimi-ku, Kyoto, Japan, 612-8450
- Owner or operator
- KYOCERA Medical Corporation (9097359)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 11, 2017
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 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 |
|---|---|---|---|---|---|---|
| December 5, 2024 | K243444 | BIOCERAM AZUL® HEAD | LZO | Substantially Equivalent | Kyocera Corporation | accessdata.fda.gov |
| November 1, 2016 | K160895 | Initia Total Hip System & BIOCERAM AZUL(R) HEAD | LZO | Substantially Equivalent | Kyocera Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Orthopedic Manual Surgical Instrument
Updated December 5, 2024. 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.