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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 K171686
Device Name Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Applicant
Choicespine
400 Erin Dr.
Knoxville,  TN  37924
Applicant Contact Kim Finch
Correspondent
Choicespine
400 Erin Dr.
Knoxville,  TN  37924
Correspondent Contact Kim Finch
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/07/2017
Decision Date 09/15/2017
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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