Device Classification Name |
Hydrogel Spacer
|
510(k) Number |
K181465 |
Device Name |
SpaceOAR System |
Applicant |
Augmenix, Inc. |
201 Burlington Road |
Bedford,
MA
01730
|
|
Applicant Contact |
Marcus Garcia |
Correspondent |
Augmenix, Inc. |
201 Burlington Road |
Bedford,
MA
01730
|
|
Correspondent Contact |
Marcus Garcia |
Regulation Number | 892.5725
|
Classification Product Code |
|
Date Received | 06/04/2018 |
Decision Date | 06/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|