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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 K212405
Device Name EMERGE™ Anterior Cervical Plate System
Applicant
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Applicant Contact Todd Wallenstein
Correspondent
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Correspondent Contact Todd Wallenstein
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/02/2021
Decision Date 09/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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