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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K222107
Device Name Black Diamond™ POCT Spinal System
Applicant
Osseus Fusion Systems
1931 Greenville Ave.
Suite 200
Dallas,  TX  75206
Applicant Contact Jonathan Rosen
Correspondent
Jalex Medical, LLC
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Daniel Johnson
Regulation Number888.3075
Classification Product Code
NKG  
Date Received07/18/2022
Decision Date 11/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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