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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K210402
Device Name Curiteva Sacroiliac Joint Fusion 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 Number888.3040
Classification Product Code
OUR  
Date Received02/10/2021
Decision Date 09/09/2021
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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