The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Kmti Hip Replacement System.
| Device ID | K203472 |
| 510k Number | K203472 |
| Device Name: | KMTI Hip Replacement System |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, 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 | OQG |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-25 |
| Decision Date | 2021-04-02 |