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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 Bone Graft, Lumbar
510(k) Number K162103
Device Name Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
Applicant
Choicespine, LP
400 Erin Dr.
Knoxville,  TN  37919
Applicant Contact KIM FINCH
Correspondent
Choicespine, LP
400 Erin Dr.
Knoxville,  TN  37919
Correspondent Contact KIM FINCH
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received07/29/2016
Decision Date 11/23/2016
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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