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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 K212028
Device Name Dark Star Navigation Instrument System
Applicant
Republic Spine, LLC
2424 N Federal Hw, Suite 257
Boca Raton,  FL  33431
Applicant Contact James Doulgeris
Correspondent
Republic Spine, LLC
2424 N Federal Hw, Suite 257
Boca Raton,  FL  33431
Correspondent Contact James Doulgeris
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/29/2021
Decision Date 09/27/2021
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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