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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K192121
Device Name Black Diamond Pedicle Screw System
Osseus Fusion Systems
2703 Mockingbird Lane, Suite 102
dallas,  TX  75235
Applicant Contact robert pace
The OrthoMedix Group, Inc.
4313 W. 3800 S.
west haven,  UT  84401
Correspondent Contact j. d. webb
Regulation Number888.3070
Classification Product Code
Date Received08/06/2019
Decision Date 10/29/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No