The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Exeter V40 Femoral Stem, Exeter X3 Rimfit Cup.
| Device ID | K193429 |
| 510k Number | K193429 |
| Device Name: | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Alexandra Kirby |
| Correspondent | Alexandra Kirby Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JDI |
| Subsequent Product Code | JDG |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-10 |
| Decision Date | 2020-08-13 |