The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Sl-plus Mia Standard And Lateral Femoral Hip Stem.
| Device ID | K082371 |
| 510k Number | K082371 |
| Device Name: | SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Jason Sells |
| Correspondent | Jason Sells 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 | 2008-08-18 |
| Decision Date | 2009-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996079746 | K082371 | 000 |
| 07611996079609 | K082371 | 000 |
| 07611996079593 | K082371 | 000 |
| 07611996079586 | K082371 | 000 |
| 07611996079579 | K082371 | 000 |
| 07611996079562 | K082371 | 000 |
| 07611996078916 | K082371 | 000 |
| 07611996078909 | K082371 | 000 |
| 07611996078893 | K082371 | 000 |
| 07611996078886 | K082371 | 000 |
| 07611996078879 | K082371 | 000 |
| 07611996078862 | K082371 | 000 |
| 07611996079616 | K082371 | 000 |
| 07611996079623 | K082371 | 000 |
| 07611996079739 | K082371 | 000 |
| 07611996079722 | K082371 | 000 |
| 07611996079715 | K082371 | 000 |
| 07611996079708 | K082371 | 000 |
| 07611996079692 | K082371 | 000 |
| 07611996079685 | K082371 | 000 |
| 07611996079678 | K082371 | 000 |
| 07611996079661 | K082371 | 000 |
| 07611996079654 | K082371 | 000 |
| 07611996079647 | K082371 | 000 |
| 07611996079630 | K082371 | 000 |
| 07611996078855 | K082371 | 000 |