510(k) DEN140030
- Device
- SpaceOAR System
- Applicant
- Augmenix, Inc.
- 510(k) number
- DEN140030
- Product code
- OVB
- Decision
- Unknown (DENG)
- Decision date
- 2015-04-01
- Date received
- 2014-10-01
- Regulation
- 892.5725
- Classification name
- Hydrogel Spacer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Noel Rolon
- Address
- 204 Second Ave., Lower Level Waltham MA US 02451 02451
FDA Registration Numbers#
- 9616684
- 1220477
- 1226146
- 9710154
- 2246552
- 3011137372
- 3010173425
- 3008729892
- 3002478693
- 2124215
- 2245304
- 3014285231
- 3005099803
- 3002807314
- 3014909464
- 1225687
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OVB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026-02-10 |
| K222972 | BioProtect Balloon Implant™ System | Bioprotect, Ltd. | 2023-08-25 |
| K220641 | Barrigel Injectable Gel | Palette Life Sciences | 2022-05-26 |
| K202224 | SpaceOAR System | Boston Scientific Corporation | 2020-08-28 |
| K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019-07-19 |
| K181465 | SpaceOAR System | Augmenix, Inc. | 2018-06-25 |