The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Polarstem Cemented Femoral Stem.
| Device ID | K203175 |
| 510k Number | K203175 |
| Device Name: | POLARSTEM Cemented Femoral Stem |
| 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 | Brad Sheals |
| Correspondent | Brad Sheals Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-26 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996096675 | K203175 | 000 |
| 07611996096699 | K203175 | 000 |
| 07611996096705 | K203175 | 000 |
| 07611996096712 | K203175 | 000 |
| 07611996096729 | K203175 | 000 |
| 07611996096736 | K203175 | 000 |
| 07611996096743 | K203175 | 000 |
| 07611996096750 | K203175 | 000 |
| 07611996096781 | K203175 | 000 |
| 07611996096798 | K203175 | 000 |
| 07611996096804 | K203175 | 000 |
| 07611996096811 | K203175 | 000 |
| 07611996096828 | K203175 | 000 |
| 07611996096835 | K203175 | 000 |
| 07611996096842 | K203175 | 000 |
| 07611996096880 | K203175 | 000 |
| 07611996096682 | K203175 | 000 |