The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Emphasys Femoral Stems.
| Device ID | K211657 |
| 510k Number | K211657 |
| Device Name: | EMPHASYS Femoral Stems |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy Ireland UC Loughbeg, IE |
| Contact | Erin Combs |
| Correspondent | Clare Hill DePuy Synthes, IRenc. 700 Orthopaedic Drive Warsaw, IL 46582 |
| Product Code | LZO |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-28 |
| Decision Date | 2021-08-05 |