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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 K191223
Device Name NAVIO
Applicant
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Applicant Contact Amy Winegarden
Correspondent
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Correspondent Contact Amy Winegarden
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/07/2019
Decision Date 06/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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