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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 K181589
Device Name Curiteva Lumbar Interbody Fusion System
Applicant
Curiteva, LLC
25127 Will Mccomb Dr., Suite 100
Tanner,  AL  35671
Applicant Contact Eric Linder
Correspondent
Curiteva, LLC
25127 Will Mccomb Dr., Suite 100
Tanner,  AL  35671
Correspondent Contact Eric Linder
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/18/2018
Decision Date 12/20/2018
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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