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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
Predetermined Change
Control Plan Authorized		 No
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