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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Growing Rod System
510(k) Number K141509
Device Name ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
Applicant
Medos Sarl
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KIRSTEN LEHMULLER
Correspondent
Medos Sarl
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KIRSTEN LEHMULLER
Regulation Number888.3070
Classification Product Code
PGM  
Date Received06/06/2014
Decision Date 08/22/2014
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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