The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Or3o Dual Mobility System.
| Device ID | K220959 |
| 510k Number | K220959 |
| 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 | Rose Beifuss |
| Correspondent | Rose Beifuss 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 | 2022-04-01 |
| Decision Date | 2022-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556800874 | K220959 | 000 |
| 00885556710593 | K220959 | 000 |
| 00885556800881 | K220959 | 000 |
| 00885556800898 | K220959 | 000 |
| 00885556800904 | K220959 | 000 |
| 00885556800911 | K220959 | 000 |
| 00885556712368 | K220959 | 000 |
| 00885556724897 | K220959 | 000 |
| 00885556800843 | K220959 | 000 |
| 00885556800850 | K220959 | 000 |
| 00885556800867 | K220959 | 000 |
| 00885556710579 | K220959 | 000 |