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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K141103
Device Name INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
Applicant
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/29/2014
Decision Date 09/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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