The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Oxinium Dh Femoral Heads.
| Device ID | K081566 |
| 510k Number | K081566 |
| Device Name: | SMITH & NEPHEW OXINIUM DH FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Contact | Jason Sells |
| Correspondent | Jason Sells SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-08-21 |
| Summary: | summary |