SpaceOAR System
K-Number: K181465 · 2018-06-25
ApplicantAugmenix, Inc.
Decision Date2018-06-25
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SpaceOAR System is a medical device manufactured by Augmenix, Inc.. It received FDA 510(k) clearance on 2018-06-25 under approval number K181465. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpaceOAR System?
SpaceOAR System is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Augmenix, Inc.. The 510(k) number is K181465.
When was SpaceOAR System approved by the FDA?
SpaceOAR System received FDA 510(k) clearance on 2018-06-25, under approval number K181465.
What company makes SpaceOAR System?
SpaceOAR System is manufactured by Augmenix, Inc..
What is the FDA product code for SpaceOAR System?
The FDA product code for SpaceOAR System is OVB.
Related Clinical Trials
Other Devices by Augmenix, Inc.
Related Devices (Code: OVB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.