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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K222291
Device Name Paradigm System
Applicant
Proprio, Inc.
111 W John Street
Suite 308
Seattle,  WA  98119
Applicant Contact Niyi Asimolowo
Correspondent
Proprio, Inc.
111 W John Street
Suite 308
Seattle,  WA  98119
Correspondent Contact Shannon Eubanks
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/01/2022
Decision Date 04/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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