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 |