País: Bielorrússia
Língua: russo
Origem: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Medos International SARL, ШВЕЙЦАРИЯ
изделия медицинского назначения
Medos International SARL
2020-10-02
RIGIDLOOP ™ CORTICAL FIXATION SYSTEM 15MM – 60MM IMPLANTS 1 ENGLISH RIGIDLOOP™ CORTICAL FIXATION IMPLANT SYSTEM – 15MM – 60MM IMPLANTS DESCRIPTION The RIGIDLOOP™ Cortical Fixation System provides a means of accurate suture fixation of tendons and ligaments in orthopedic reconstructive surgery. The device consists of a titanium implant with a pre- attached non-absorbable suture loop. The implant is preloaded with a white UHMWPE (ultra high molecular weight polyethylene) leading utility suture and a green #5 Ethibond ® trailing suture, and is offered in a size range of 15-60mm. MATERIALS SUTURE LOOP OF IMPLANT: Ultra high molecular weight polyethylene METAL COMPONENT OF IMPLANT: Titanium alloy which meets ASTM standard F136. INDICATIONS The RIGIDLOOP Cortical Fixation System is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs. 2 CONTRAINDICATIONS • Physical conditions which would eliminate, or tend to eliminate, adequate implant support or retard healing, e.g., blood supply limitations, infections. • Implant/material sensitivity/foreign body sensitivity. • Conditions which tend to pre-empt the patient’s ability or healing period, such as senility, mental illness or alcoholism. WARNINGS • Do not resterilize. The components are provided sterile, for single use only. This product has not been designed to be reused/re-sterilized. Reprocessing may lead to changes in material characteristics such as deformation and material degradation which may impact the strength of the implant and compromise device performance. Reprocessing of single use devices can also cross-contaminate leading to patient infection. These risks may potentially affect patient safety. • Do not attempt clinical use of the RIGIDLOOP Cortical Fixation Implant before reviewing the instructions for use. • The surgeon using this device must be familiar with the appropriate surgical techniques prior to use. PRECAUTIONS • Contents sterile unless package has been opened or damaged. • Do no Leia o documento completo