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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K232792
Device Name icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)
Applicant
icotec AG
Industriestrasse 12
9450 Altstaetten (SG),  CH
Applicant Contact Marina Hess
Correspondent
MCRA, LLC
803 7th Steet NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received09/11/2023
Decision Date 04/05/2024
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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