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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 K162160
Device Name Preference Elite Pedicle Screw System
Applicant
AMEDICA CORPORATION
1885 W 2100 S
salt lake city,  UT  84119
Applicant Contact shanna ryan
Correspondent
AMEDICA CORPORATION
1885 West 2100 South
salt lake city,  UT  84119
Correspondent Contact shanna ryan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received08/02/2016
Decision Date 11/18/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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