The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Polarstem Standard And Lateral Femoral Stems With Ti/ha.
| Device ID | K130728 |
| 510k Number | K130728 |
| Device Name: | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Sameer Mansour |
| Correspondent | Sameer Mansour SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996162714 | K130728 | 000 |
| 07611996118674 | K130728 | 000 |
| 07611996114829 | K130728 | 000 |
| 07611996112580 | K130728 | 000 |
| 00885556590317 | K130728 | 000 |
| 00885556535578 | K130728 | 000 |