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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 K162232
Device Name MOSS 100 Pedicle Screw System
Applicant
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Straße 23
Villingen-Schwenningen,  DE 78054
Applicant Contact Gerd Federle
Correspondent
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Straße 23
Villingen-Schwenningen,  DE 78054
Correspondent Contact Gerd Federle
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received08/08/2016
Decision Date 11/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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