Фиксаторы имплантируемые для проведения артроскопических операций: фиксатор-застежка с фиксированной петлей RIGIDLOOP Cortical Fixation Implant, (размеры, мм: 15; 20; 25; 30; 35; 40; 45; 50; 55; 60; Extra Large)

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Medos International SARL, ШВЕЙЦАРИЯ

класс:

изделия медицинского назначения

Производитель:

Medos International SARL

Дата Авторизация:

2020-10-02

Характеристики продукта

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