Medical device - MSA

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Medical device

MSA code	20808
Basic UDI-DI	0705034a001805Z
Seadme klass	Meditsiiniseade
Medical Device Nomenclature
Risk class	IIb
Appliance	-
Device name (in Estonian)	EXPEDIUM-i anterioorne lülisambasüsteem - monoaksiaalne kruvi
Device name (in English)	EXPEDIUM Anterior Spine System - monoaxial screw
Intended use (is Estonian)	Anterioorne lülisambasüsteem EXPEDIUM on ette nähtud rindkere lülisamba (T4 kuni L4) anterolateraalseks kruviga fikseerimiseks lisandina fusioonile väljaarenenud luustikuga patsientidel.
Intended use (in English)	The EXPEDIUM Anterior Spine System is intended for anterolateral screw fixation of the thoracolumbar spine (T4 to L4) as an adjunct to fusion in skeletally mature patients.
Type/model/article number	187702760, 187702757, 187702755, 187702752, 187702750, 187702747, 187702745, 187702742, 187702740, 187702737, 187702735, 187702732, 187702730, 187702727, 187702520, 187702522, 187702525, 187702527, 187702725, 187702530, 187702532, 187702535, 187702540, 187702545, 187702620, 187702660, 187702622, 187702655, 187702625, 187702627, 187702630, 187702650, 187702647, 187702645, 187702642, 187702640, 187702637, 187702635, 187702632
Notified body	2797
Manufacturer	Medos International SARL
Authorised representative	DePuy Ireland UC
In register from	07/22/2024
Entry status	Active
Device comments, keywords	MDR
Reimbursed by EHIF	Tervisekassa soodustus puudub

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