The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Kyocera Bipolar Hip System.
| Device ID | K200709 |
| 510k Number | K200709 |
| Device Name: | Kyocera Bipolar Hip System |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Kyocera Medical Technologies, Inc. 1200 California St Suite 210 Redlands, CA 92374 |
| Contact | Anthony Debenedictis |
| Correspondent | Sharyn Orton MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-04-17 |