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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrogel Spacer
510(k) Number K182971
Device Name SpaceOAR Vue Hydrogel
Applicant
Augmenix, Inc.
21 Burlington Rd.
Bedford,  MA  01730
Applicant Contact Marcus Garcia
Correspondent
Boston Scientific
201 Burlington Rd.
North Bldg.
Bedford,  MA  01730
Correspondent Contact Marcus Garcia
Regulation Number892.5725
Classification Product Code
OVB  
Date Received10/26/2018
Decision Date 07/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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