Data / Medical devices / Japan / KYOCERA Medical Corporation Shiga Higashiomi Plant
KYOCERA Medical Corporation Shiga Higashiomi Plant: FDA-registered device maker in Higashiomi-shi Shiga, Japan, 2 510(k) clearances
KYOCERA Medical Corporation Shiga Higashiomi Plant is registered with the FDA (registration 3006536454) in Higashiomi-shi Shiga, Japan. It lists 4 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 3, 2026.
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- FDA registration number
- 3006536454
- Address
- 10-1 Kawai-Cho, Higashiomi-shi Shiga, Japan, 529-1571
- Owner or operator
- KYOCERA Medical Corporation (9097359)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 1, 2007
- Registered through
- 2027
- Brand names listed
- ATH CERAMIC UHMWPE TOTAL HIP SYSTEM KINAMED 32MM BIOCERAM-Z TOTAL HIP BALL, CARDO MEDICAL CERAMIC HIP SYSTEM 32mm and 36mm Alumina Ceramic Femoral Heads, DYNASTY ACETABULAR SYSTEM 50mm and 54mm Alumina Ceramic Femoral Heads, DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads, DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads, KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL, KINAMED 26MM BIOCERAM-Z TOTAL HIP FEMORAL BALL, KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | 3 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | 3 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Manufacturer | 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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- All makers of Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.