The following data is part of a premarket notification filed by Augmenix, Inc with the FDA for Spaceoar Vue Hydrogel.
| Device ID | K182971 |
| 510k Number | K182971 |
| Device Name: | SpaceOAR Vue Hydrogel |
| Classification | Hydrogel Spacer |
| Applicant | Augmenix, Inc 21 Burlington Road Bedford, MA 01730 |
| Contact | Marcus Garcia |
| Correspondent | Marcus Garcia Boston Scientific 201 Burlington Road North Building Bedford, MA 01730 |
| Product Code | OVB |
| CFR Regulation Number | 892.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2019-07-19 |