The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sl-plus Standard And Lateral Femoral Stem With Ti/ha Coating.
| Device ID | K120211 |
| 510k Number | K120211 |
| Device Name: | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | John Connor |
| Correspondent | John Connor SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-24 |
| Decision Date | 2012-07-19 |
| Summary: | summary |