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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, Cervical
510(k) Number K260038
Device Name E3D™-C Interbody System
Applicant
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Applicant Contact Quynh Tran
Correspondent
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Correspondent Contact Quynh Tran
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received01/06/2026
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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