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 Number | 888.3041
|
Classification Product Code |
|
Date Received | 05/04/2022 |
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
|
|
|