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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 K172816
Device Name TiGer Shark™ System
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  
Date Received09/18/2017
Decision Date 01/26/2018
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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