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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K171582
Device Name NEO Pedicle Screw System™
Applicant
Neo Medical S.A.
Route de Lausanne 157A
villette (lavaux),  CH 1096
Applicant Contact jonas larsson
Correspondent
confinis USA
2511 Saint Ignatius Court
orlando,  FL  32835
Correspondent Contact samuel lainez
Regulation Number888.3070
Classification Product Code
NKB  
Date Received05/31/2017
Decision Date 09/12/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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