Medical device - MSA

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Medical device

EMDDB code	22725
Basic UDI-DI	0885556SN000513LY
Seadme klass	Meditsiiniseade
Medical Device Nomenclature
Risk class	III
Appliance	-
Device name (in Estonian)	REFLECTION Puusanapasüsteem
Device name (in English)	REFLECTION Acetabular System
Intended use (is Estonian)	Smith & Nephew puusanapakomponendid on ette nähtud puusa täielikuks artroplastikaks luuküpsetel patsientidel. REFLECTION™ süsteem on mõeldud tsemendiga või ilma tsemendita kasutamiseks.
Intended use (in English)	The Smith % Nephew Acetabular System Components are intented for total hip arthroplasty in skeletally mature patients. The REFLECTION System is intended for cemented or cementless use.
Type/model/article number	71358001, 71358002, 71358003, 71358004, 71358005, 71358006, 71358007, 71358008, 71358023, 71358024, 71358025, 71358026, 71358027, 71358028, 71358029, 71358034, 71358035, 71358036, 71358037, 71358038, 71358039, 71358065, 71358066, 71358067, 71358068, 71358069
Notified body	2797
Manufacturer	Smith & Nephew Inc.
Authorised representative	Smith & Nephew Operations BV
In register from	11/04/2025
Entry status	Active
Device comments, keywords	MDR
Reimbursed by EHIF	Tervisekassa soodustus puudub

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