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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 K233744
Device Name Curiteva Porous PEEK Lumbar Interbody Fusion System
Applicant
Curiteva, Inc.
25127 Will Mccomb Dr.
Tanner,  AL  35671
Applicant Contact Eric Linder
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/22/2023
Decision Date 01/18/2024
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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