The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Slr-plus Standard And Lateral Femoral Stems.
| Device ID | K093991 |
| 510k Number | K093991 |
| Device Name: | SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Shereen Myers |
| Correspondent | Shereen Myers SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDJ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996088359 | K093991 | 000 |
| 07611996088229 | K093991 | 000 |
| 07611996088212 | K093991 | 000 |
| 07611996088205 | K093991 | 000 |
| 07611996088199 | K093991 | 000 |
| 07611996088182 | K093991 | 000 |
| 07611996088175 | K093991 | 000 |
| 07611996088168 | K093991 | 000 |
| 07611996088151 | K093991 | 000 |
| 07611996088144 | K093991 | 000 |
| 07611996088236 | K093991 | 000 |
| 07611996088250 | K093991 | 000 |
| 07611996088342 | K093991 | 000 |
| 07611996088335 | K093991 | 000 |
| 07611996088328 | K093991 | 000 |
| 07611996088311 | K093991 | 000 |
| 07611996088304 | K093991 | 000 |
| 07611996088298 | K093991 | 000 |
| 07611996088281 | K093991 | 000 |
| 07611996088274 | K093991 | 000 |
| 07611996088267 | K093991 | 000 |
| 07611996088137 | K093991 | 000 |