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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 Integrated Fixation, Lumbar
510(k) Number K250845
Device Name Curiteva Porous PEEK Standalone ALIF System
Applicant
Curiteva, Inc.
25127 Will Mccomb Dr.
Tanner,  AL  35671
Applicant Contact Eric Linder
Correspondent
Curiteva, Inc.
25127 Will Mccomb Dr.
Tanner,  AL  35671
Correspondent Contact Eric Linder
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   PHM  
Date Received03/20/2025
Decision Date 06/18/2025
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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