The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sl-plus Standard And Lateral Hip Stems.
| Device ID | K072852 |
| 510k Number | K072852 |
| Device Name: | SL-PLUS STANDARD AND LATERAL HIP 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 | Nicholas B Tabrizi |
| Correspondent | Nicholas B Tabrizi 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 | 2007-10-04 |
| Decision Date | 2008-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996078015 | K072852 | 000 |
| 07611996078626 | K072852 | 000 |
| 07611996078633 | K072852 | 000 |
| 07611996078640 | K072852 | 000 |
| 07611996078657 | K072852 | 000 |
| 07611996078664 | K072852 | 000 |
| 07611996078671 | K072852 | 000 |
| 07611996078688 | K072852 | 000 |
| 07611996078695 | K072852 | 000 |
| 07611996078619 | K072852 | 000 |
| 07611996078121 | K072852 | 000 |
| 07611996078114 | K072852 | 000 |
| 07611996078022 | K072852 | 000 |
| 07611996078039 | K072852 | 000 |
| 07611996078046 | K072852 | 000 |
| 07611996078053 | K072852 | 000 |
| 07611996078060 | K072852 | 000 |
| 07611996078077 | K072852 | 000 |
| 07611996078084 | K072852 | 000 |
| 07611996078107 | K072852 | 000 |
| 07611996078701 | K072852 | 000 |
| 07611996078718 | K072852 | 000 |
| 07611996127041 | K072852 | 000 |
| 07611996127058 | K072852 | 000 |
| 07611996127065 | K072852 | 000 |
| 07611996127072 | K072852 | 000 |
| 07611996127089 | K072852 | 000 |
| 07611996127096 | K072852 | 000 |
| 07611996127102 | K072852 | 000 |
| 07611996127119 | K072852 | 000 |
| 07611996127034 | K072852 | 000 |
| 07611996127027 | K072852 | 000 |
| 07611996127010 | K072852 | 000 |
| 07611996078725 | K072852 | 000 |
| 07611996078732 | K072852 | 000 |
| 07611996078749 | K072852 | 000 |
| 07611996122367 | K072852 | 000 |
| 07611996122374 | K072852 | 000 |
| 07611996122381 | K072852 | 000 |
| 07611996122398 | K072852 | 000 |
| 07611996127003 | K072852 | 000 |
| 07611996078091 | K072852 | 000 |