Font size
Font spacing
Contrast
Cancel
Ravimiamet
FOR VISUALLY IMPAIRED

Medical device

EMDDB code 20682
Basic UDI-DI 7611819a00261JE
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIb
Appliance -
Device name (in Estonian) Lukustuskruvi Synapse
Device name (in English) Locking Screw Synapse
Intended use (is Estonian) Süsteem SYNAPSE on mõeldud lülisamba kaelaosa ja rinnaosa ülaosa tagumiseks fikseerimiseks abivahendina fusioonile väljaarenenud luustikuga patsientidel. Süsteem OC FUSION koos tagumise kruvi-varras-süsteemiga on mõeldud kuklaluu-kaela ühenduse ja kaela/rinnaosa ülaosa stabiliseerimiseks (Kukal-T3).
Intended use (in English) The SYNAPSE System is intended for posterior stabilization of the cervical spine and upper thoracic spine as an adjunct to fusion in skeletally mature patients. The OC FUSION System in combination with a posterior screw-rod system is intended to provide stabilization of the occipito-cervical junction and cervical/upper thoracic spine (Occiput-T3).
Type/model/article number 04.614.508, 04.614.508S
Notified body 0123
Manufacturer Synthes GmbH
Authorised representative DePuy Ireland UC
In register from 06/19/2024
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
ID Purpose of the file Added Title
Distribution
ID No. Distributors name Distributors code From

Piksel

x
Database Nomenclature Help Forms Open data