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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 St., Suite 308
Seattle,  WA  98119
Applicant Contact Niyi Asimolowo
Correspondent
Proprio, Inc.
111 W. John St., 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
Predetermined Change
Control Plan Authorized		 No
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