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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K152475
Device Name FORZA PTC Spacer System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact NATALIA VOLOSEN
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact NATALIA VOLOSEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/31/2015
Decision Date 01/14/2016
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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