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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K121850
Device Name Typhoon(TM) Facet Screw Fixation System
Applicant
CHOICE SPINE, LP
400 Erin Dr
KNOXVILLE,  TN  37919
Applicant Contact KIM FINCH
Correspondent
CHOICE SPINE, LP
400 Erin Dr
KNOXVILLE,  TN  37919
Correspondent Contact KIM FINCH
Classification Product Code
MRW  
Date Received06/25/2012
Decision Date 09/20/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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