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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 K132852
Device Name PEEK CAGE FOR THE VERTEBRAL SPINE
Applicant
Neoortho Produtos Ortopedicos S/A
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
Neoortho Produtos Ortopedicos S/A
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received09/11/2013
Decision Date 05/29/2014
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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