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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device
510(k) Number K183197
Device Name PYRAMESH™ Implant System
Applicant
Medtronic Sofamor Danek USA, INC.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact ANkit K. Shah
Correspondent
Medtronic Sofamor Danek USA, INC.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact ANkit K. Shah
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/19/2018
Decision Date 04/04/2019
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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