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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K261882
Device Name Pisces-SC Standalone Cervical Interbody System
Applicant
Osseus Fusions Systems, LLC
1931 Greenville Ave.
Suite 200
Dallas,  TX  75206
Applicant Contact Jonathan Rosen
Correspondent
Osseus Fusions Systems, LLC
1931 Greenville Ave.
Suite 200
Dallas,  TX  75206
Correspondent Contact Jonathan Rosen
Regulation Number888.3080
Classification Product Code
OVE  
Date Received06/05/2026
Decision Date 08/21/2026
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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