The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Polarstem Collared (standard And Lateral) And Valgus Femoral Stem With Ti/ha.
| Device ID | K143739 |
| 510k Number | K143739 |
| Device Name: | POLARSTEM Collared (Standard And Lateral) And Valgus Femoral Stem 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 | Jeff Sprague |
| Correspondent | Jeff Sprague 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 | 2014-12-30 |
| Decision Date | 2015-04-20 |
| Summary: | summary |