Kyocera Corporation · 89-08 · JAPAN
For Kyocera Corporation, import alert is 89-08; country is JAPAN; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented; date published is 09/16/2009; address is 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN, verified against its source on 2026-09-30.
- Firm
- Kyocera Corporation verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- JAPAN verified
- Address
- 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN verified
- Date published
- 09/16/2009 verified
- Product code
- 87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented verified
- FDA notes
- Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005 verified
What the source says
Kyocera Corporation Date Published : 09/16/2009 10 1 , Kawai; Gamo-Chogamo Block, , Gamogun, Shiga JAPAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
87 L - - ZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Date Published: 09/16/2009 Notes: Ceramic Aluminum and Zirconium Balls for Hip Implants 1/13/2005
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.