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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 K250403
Device Name Catamaran SI Joint Fusion System
Applicant
Tenon Medical
104 Cooper Ct.
Los Gatos,  CA  95032
Applicant Contact Richard Ginn
Correspondent
MCRA, LLC
803 7th St. NW
Fourth Floor
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3040
Classification Product Code
OUR  
Date Received02/12/2025
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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