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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 K252962
Device Name DYNAMIS™ Navigation System
Applicant
Promethean Restorative, LLC
330 Perry St., Suite 210
Castle Rock,  CO  80104
Applicant Contact Glenn Bowman
Correspondent
Promethean Restorative, LLC
330 Perry St., Suite 210
Castle Rock,  CO  80104
Correspondent Contact Glenn Bowman
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/16/2025
Decision Date 01/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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