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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 K192495
Device Name Black Diamond Navigation Instruments
Applicant
Osseus Fusion Systems
2703 Mockingbird Ln., Suite 102
Dallas,  TX  75235
Applicant Contact Robert Pace
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J. D. Webb
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/11/2019
Decision Date 01/17/2020
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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