Страна: Беларусь
Язык: русский
Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Medos International SARL, ШВЕЙЦАРИЯ
изделия медицинского назначения
Medos International SARL
2020-09-03
LATARJET EXPERIENCE INSTABILITY SHOULDER SYSTEM - IMPLANTS 1 ENGLISH DESCRIPTION STERILE LATARJET (BRISTOW) SCREW STERILE TOP HAT The implants for the Latarjet EXPERIENCE Instability Shoulder System are single-patient use titanium implants supplied STERILE. Sterile Latarjet EXPERIENCE screws include the following: # ITEM DESCRIPTION CAT# 1 Sterile Top Hat 288231 2 Sterile Latarjet Screw 28mm 288222 3 Sterile Latarjet Screw 30mm 288223 4 Sterile Latarjet Screw 32mm 288224 5 Sterile Latarjet Screw 34mm 288225 6 Sterile Latarjet Screw 36mm 288226 7 Sterile Latarjet Screw 38mm 288227 8 Sterile Latarjet Screw 40mm 288228 9 Sterile Latarjet Screw 42mm 288229 10 Sterile Latarjet Screw 44mm 288230 2 INDICATIONS The Latarjet EXPERIENCE Cortical Screw Set is intended to provide the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries. CONTRAINDICATIONS • Cases when there is an active infection. • Conditions which tend to retard healing, such as blood supply limitations, previous infections, etc. • Insufficient quantity or quality of bone. • Conditions that restrict the patient’s ability or willingness to follow post-operative instructions during the healing process. • Foreign body sensitivity–where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. • These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. WARNINGS • Federal Law (United States of America) restricts this Device to sale by, or on the order of a physician. • The Screws may be used with or without the Top Hats – the decision is at the discretion of the physician. • The Devices should be inspected prior to use to ensure absence of damage. • The Devices are supplied STERILE and do not require pre-use processing. • The Devices are intended for single-patient use only, reusing or reprocessing the implant may result in bio-contamin Прочитать полный документ