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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 K230817
Device Name TORPEDO Implant System®
Applicant
Deltacor GmbH
Rudolf-Diesel-Str. 10
Werneck,  DE D-97440
Applicant Contact Maximilian Reuss
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Lucas Tatem
Regulation Number888.3040
Classification Product Code
OUR  
Date Received03/24/2023
Decision Date 01/19/2024
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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