The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Modular Femoral Head.
| Device ID | K061243 |
| 510k Number | K061243 |
| Device Name: | SMITH & NEPHEW MODULAR FEMORAL HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino Rouss |
| Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-07-17 |
| Summary: | summary |