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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 K180818
Device Name Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Applicant
Tenon Medical, Inc.
2100 Omega Road Suite F
San Ramon,  CA  94583
Applicant Contact Kal Mentak
Correspondent
JGC, LLC
2100 Omega Road, Suite F
San Ramon,  CA  94583
Correspondent Contact Jeannie Cecka
Regulation Number888.3040
Classification Product Code
OUR  
Date Received03/29/2018
Decision Date 06/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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