The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. R3™ Constrained Liner.
| Device ID | K162641 |
| 510k Number | K162641 |
| Device Name: | Smith & Nephew, Inc. R3™ Constrained Liner |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Natalie P. Williams |
| Correspondent | Dongeun Kim Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-22 |
| Decision Date | 2017-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556715161 | K162641 | 000 |
| 00885556789681 | K162641 | 000 |
| 00885556877685 | K162641 | 000 |
| 00885556878156 | K162641 | 000 |
| 00885556882290 | K162641 | 000 |
| 00885556882283 | K162641 | 000 |
| 00885556882702 | K162641 | 000 |
| 00885556882696 | K162641 | 000 |
| 00885556886571 | K162641 | 000 |
| 00885556908662 | K162641 | 000 |
| 00885556908655 | K162641 | 000 |
| 00885556908648 | K162641 | 000 |
| 00885556914373 | K162641 | 000 |
| 00885556914335 | K162641 | 000 |
| 00885556770313 | K162641 | 000 |
| 00885556770795 | K162641 | 000 |
| 00885556713334 | K162641 | 000 |
| 00885556713327 | K162641 | 000 |
| 00885556713310 | K162641 | 000 |
| 00885556712023 | K162641 | 000 |
| 00885556709863 | K162641 | 000 |
| 00885556709856 | K162641 | 000 |
| 00885556709849 | K162641 | 000 |
| 00885556709832 | K162641 | 000 |
| 00885556709825 | K162641 | 000 |
| 00885556709818 | K162641 | 000 |
| 00885556653487 | K162641 | 000 |
| 00885556590874 | K162641 | 000 |
| 00885556590782 | K162641 | 000 |
| 00885556914328 | K162641 | 000 |