The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Tesera Trabecular Technologies (t3) Acetabular Shell System, Porous Acetabular Cup System.
| Device ID | K200328 |
| 510k Number | K200328 |
| Device Name: | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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 Avenue 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 | 2020-02-10 |
| Decision Date | 2020-03-11 |