The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sl-plus Mia Femoral Stems With Ti/ha Coating.
| Device ID | K122296 |
| 510k Number | K122296 |
| Device Name: | SL-PLUS MIA FEMORAL STEMS 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2012-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996092998 | K122296 | 000 |
| 07611996092851 | K122296 | 000 |
| 07611996092844 | K122296 | 000 |
| 07611996092837 | K122296 | 000 |
| 07611996092820 | K122296 | 000 |
| 07611996092813 | K122296 | 000 |
| 07611996092806 | K122296 | 000 |
| 07611996092790 | K122296 | 000 |
| 07611996092783 | K122296 | 000 |
| 07611996092776 | K122296 | 000 |
| 07611996092769 | K122296 | 000 |
| 07611996092752 | K122296 | 000 |
| 07611996092868 | K122296 | 000 |
| 07611996092875 | K122296 | 000 |
| 07611996092981 | K122296 | 000 |
| 07611996092974 | K122296 | 000 |
| 07611996092967 | K122296 | 000 |
| 07611996092950 | K122296 | 000 |
| 07611996092943 | K122296 | 000 |
| 07611996092936 | K122296 | 000 |
| 07611996092929 | K122296 | 000 |
| 07611996092912 | K122296 | 000 |
| 07611996092905 | K122296 | 000 |
| 07611996092899 | K122296 | 000 |
| 07611996092882 | K122296 | 000 |
| 07611996092745 | K122296 | 000 |