The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Oxinium Dh Fermoral Heads.
| Device ID | K161233 |
| 510k Number | K161233 |
| Device Name: | OXINIUM DH Fermoral Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Applicant | SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
| Contact | Mike Scott |
| Correspondent | Mike Scott SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016 |
| Product Code | MBL |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-12-14 |
| Summary: | summary |