Profile: Mar-Lee Companies is involved in plastics injection molding, providing technologically advanced contract manufacturing, essential for today's complex product designs. The products we manufacture are used in a diverse range of medical/biomedical & pharmaceutical markets such as endoscopy, laparoscopy, cardiothoracic surgery, wound closure, glucose monitoring, soft tissue re-attachment, sports medicine, orthopedic joint reconstruction and medical packaging. We also offer bio resorbable polymer molding materials including polylactic acid (PLA) and other similar biomedical resins. Our PLA is a biopolymer made from renewable natural sources such as corn-starch and sugarcane. Polylactic acid can be used in place of petroleum-based polymers. There are many applications for this material, including the fairly common absorbable suture, as well as absorbable bone screws and anchors for fixation devices and soft tissue re-attachment. Other applications include implantable stents, devices used in fusion and structural based applications for spine & maxillofacial surgical applications.
FDA Registration Number: 3004014152
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| • Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |