The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spaceoar System.
| Device ID | K202224 |
| 510k Number | K202224 |
| Device Name: | SpaceOAR System |
| Classification | Hydrogel Spacer |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jeanne Otoole |
| Correspondent | Jeanne Otoole Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | OVB |
| CFR Regulation Number | 892.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2020-08-28 |