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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K233360
Device Name Curiteva Thoracolumbar Plate System
Applicant
Curiteva, Inc.
25127 Will Mccomb Dr., Suite 100
Tanner,  AL  35671
Applicant Contact Eric Linder
Correspondent
Curiteva, Inc.
25127 Will Mccomb Dr., Suite 100
Tanner,  AL  35671
Correspondent Contact Eric Linder
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/29/2023
Decision Date 02/29/2024
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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