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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K191748
Device Name Genesys Spine Sacroiliac Joint Fusion System
Applicant
Genesys Spine
1250 S. Capital Of Texas Highway
Bldg. 3, Suite 600
Austin,  TX  78746
Applicant Contact William W. Sowers
Correspondent
Genesys Spine
1250 S. Capital Of Texas Highway
Bldg. 3, Suite 600
Austin,  TX  78746
Correspondent Contact William W. Sowers
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/01/2019
Decision Date 09/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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