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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 Integrated Fixation, Cervical
510(k) Number K170953
Device Name Tomcat Cervical Spinal 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
OVE  
Date Received03/31/2017
Decision Date 04/21/2017
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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