Bethlehem, Pennsylvania, September 1, 2021/PRNewswire/ — Tyber Medical, LLC, a leading manufacturer of orthopedic equipment, provides private-label orthopedic implants for the trauma, extremity, and spine markets, earning its second place One and the largest U.S. Food and Drug Administration (FDA) 510(k) approved its expanded series of anatomical plating systems. Tyber Medical has more than 1,500 SKUs and now offers the most comprehensive combination of limb fixation equipment. The series includes more than 73 different indication-specific anatomical plate series, which are extensively developed in conjunction with CT scans, clinical data, cadaver laboratory, and consultation with industry-leading plastic surgery and podiatric surgeons.
"Tyber Medical now provides a comprehensive electroplating solution that can connect different indications and proliferate throughout the body to address long and short bone traumas and deformities," said Melissa Coale, Tyber Medical's Director of R&D.
"Our second and largest FDA clearance makes Tyber Medical a complete source of orthopedic plating for our partners and the surgeons they serve," said Tyber Medical CEO Jeff Tyber. “It’s been less than 12 months since we first received FDA approval. This highlights the speed at which we can use clinical research development, testing, and iteration to fill our partner portfolio with innovative solutions that benefit patient outcomes. Whitespace."
This newly approved indication category includes microfractures/small bones, long bone fractures, and ankle fractures/fusion plates. Tyber Medical’s Mini-frag/Small Bone bone plate contains a series of stainless steel and titanium standard and variable locking compression plates and screws of different lengths, thicknesses and configurations. The system solves the stability problems of fractures, osteotomies, joint fusion, nonunion, and fusion of small bones and small bone fragments with hands, wrists, feet and ankles. The ankle steel plate line is used for the fixation of medium/large bones, multi-segment containment, and reconstruction and revision surgery.
Tyber Medical’s long bone fracture plate consists of a straight, low-contact locking plate and a 1/3 locking tube plate. These plates use mixed cortex/cancellous threads, with variable angle locking screws and standard non-locking screws. It is used for osteotomy and nonunion and fixation of clavicle, scapula, olecranon, humerus, radius, ulna and fibula fractures. Tyber Medical Ankle Fracture/Fusion System is designed to solve various indications in the reconstruction of the ankle joint and distal tibia/fibula fixation surgery, with various locking plate types suitable for various fibula and tibia positions. The indications for this system include the fixation of distal tibial fractures, including ankle fractures, intra- and extra-articular fractures, osteotomies, medial malleolus fractures, nonunion of the metaphysis and diaphyseal area of the distal fibula, and calcaneus; tibia/ The long bones at the distal end of the fibula.
The titanium system adopts color anodizing treatment, which can easily identify the size and align with the color coding instrument. Tyber Medical plans to launch a new fixation system in 2022, and at the same time actively strive for the CE mark, using the company's global clinical registry to collect post-marketing clinical follow-up (PMCF).
Tyber Medical is committed to developing fast-access, innovative orthopedic equipment technology to improve patient care and healing. The company's extensive medical device product portfolio, including a wide range of hollow screw technology series, through vertically integrated design, engineering, manufacturing, quality management, supervision, and clinical research, effectively supports the product supply of its partners in just four months Gaps and MDR compliance.
About Tyber Medical, LLC Tyber Medical, LLC is a leading orthopedic device manufacturer that provides FDA-approved and CE-marked private-label, enhanced product portfolio, and regulatory approved orthopedic implants for the spinal intervertebral space and extremities/trauma markets. Into things. Tyber Medical provides customers with fast and seamless market access. Since its establishment in 2012, the company has released more than 50 limb/trauma/spine systems. Tyber Medical aims to develop and utilize differentiated bioengineering technologies, including different surface treatments and coatings, to manufacture advanced orthopedic implants.
Contact: Eric Dickson, Tyber Medical Phone: 610-849-1710 Email: edickson@tybermed.com
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