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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K183588
Device Name Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
Applicant
Choicespine
400 Erin Dr.
Knoxville,  TN  37919
Applicant Contact Kim Finch
Correspondent
Choicespine
400 Erin Dr.
Knoxville,  TN  37919
Correspondent Contact Kim Finch
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
PLR  
Date Received12/21/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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