The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Or3o Dual Mobility System.
| Device ID | K191002 |
| 510k Number | K191002 |
| Device Name: | OR3O Dual Mobility System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Mike Scott |
| Correspondent | Mike Scott Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556712436 | K191002 | 000 |
| 00885556710548 | K191002 | 000 |
| 00885556712221 | K191002 | 000 |
| 00885556712238 | K191002 | 000 |
| 00885556712245 | K191002 | 000 |
| 00885556712252 | K191002 | 000 |
| 00885556712269 | K191002 | 000 |
| 00885556712276 | K191002 | 000 |
| 00885556712283 | K191002 | 000 |
| 00885556710531 | K191002 | 000 |
| 00885556710524 | K191002 | 000 |
| 00885556710517 | K191002 | 000 |
| 00885556712320 | K191002 | 000 |
| 00885556710449 | K191002 | 000 |
| 00885556710456 | K191002 | 000 |
| 00885556710463 | K191002 | 000 |
| 00885556710470 | K191002 | 000 |
| 00885556710487 | K191002 | 000 |
| 00885556710494 | K191002 | 000 |
| 00885556710500 | K191002 | 000 |
| 00885556712290 | K191002 | 000 |
| 00885556712306 | K191002 | 000 |
| 00885556710562 | K191002 | 000 |
| 00885556710586 | K191002 | 000 |
| 00885556710609 | K191002 | 000 |
| 00885556710616 | K191002 | 000 |
| 00885556710623 | K191002 | 000 |
| 00885556710630 | K191002 | 000 |
| 00885556710647 | K191002 | 000 |
| 00885556710654 | K191002 | 000 |
| 00885556710555 | K191002 | 000 |
| 00885556712429 | K191002 | 000 |
| 00885556712412 | K191002 | 000 |
| 00885556712313 | K191002 | 000 |
| 00885556712337 | K191002 | 000 |
| 00885556712344 | K191002 | 000 |
| 00885556712351 | K191002 | 000 |
| 00885556712375 | K191002 | 000 |
| 00885556712382 | K191002 | 000 |
| 00885556712399 | K191002 | 000 |
| 00885556712405 | K191002 | 000 |
| 00885556710661 | K191002 | 000 |