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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name absorbable metallic bone fixation fastener
De Novo Number DEN220030
Device Name RemeOs™ Screw LAG Solid
Requester
bioretec ltd.
yrittäjänkulma 5
tampere,  FI fi-33710
Contact mari ruotsalainen
Regulation Number888.3041
Classification Product Code
QJD  
Date Received05/04/2022
Decision Date 03/29/2023
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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