FDA 510(k) K182971, SpaceOAR Vue Hydrogel, by Augmenix, Inc.
FDA 510(k) K182971, SpaceOAR Vue Hydrogel, by Augmenix, Inc.
Device Classification Name: Hydrogel Spacer
510(k) Number: K182971
Device Name: SpaceOAR Vue Hydrogel
Applicant: Augmenix, Inc.
Regulation Number: 892.5725
Classification Product Code: OVB
Date Received: 10/26/2018
Decision Date: 07/19/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 1,586
Fully redacted pages: 1,291
Content pages: 295
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