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FDA 510(k), K181465, SpaceOAR System
FDA 510(k), K181465, SpaceOAR System
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510(K) Number: K181465
Device Name: SpaceOAR System
Manufacturer: Marcus Garcia
Device Classification Name: Hydrogel Spacer
Regulation Number: OVB
Classification Product Code: KXA
Date Received: 06/04/2018
Decision Date: 06/25/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SpaceOAR System
Manufacturer: Marcus Garcia
Device Classification Name: Hydrogel Spacer
Regulation Number: OVB
Classification Product Code: KXA
Date Received: 06/04/2018
Decision Date: 06/25/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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