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OrthoKinetic Technologies, LLC
2790 Creekbridge Court
Southport, NC 28461 US
OrthoKinetic Technologies, LLC (OKT) is a regulatory and pre-clinical testing and advisory consulting firm. It provides regulatory guidance, assists with regulatory submissions, serves as a liason to the FDA and/or OUS regulatory agencies for domestic and international medical device companies. The company owner and additional OKT engineers have extensive experience in litigation support and forensic engineering and have served as expert witnesses in numerous brain and spine injury cases, product liability cases, including medical device failure analysis and testimony (DEFENSE ONLY).
OKT is the parent company of OrthoKinetic Testing Technologies, LLC (OKT2) which is an A2LA accredited test facility with accreditation for ISO and ASTM standardized tests in orthopedics and spine, and allograft tissue testing. It is one of the few accredited test facilities that is accredited for tissue testing. The engineers at OKT2 have extensive years of experience in this testing. Product testing and certification, sports equipment, textiles, toys, safety.
A2LA accredited medical device testing facility provides the following services: standardized mechanical tests per American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards for multiple types of devices and allograft tissue. Additional services involve the assessment of implant strength, durability, wear simulation and particulate analyses, fatigue resistance, resistance to corrosion multiaxis strength testing, low and high cycle fatigue, cyclic stress and strain, burst and rupture, cyclic rupture, creep, elongation, bending, crack propagation, stress relaxation, suture and tissue retention, fracture toughness, coating integrity, surgical tooling and delivery system evaluation, and failure analyses, computer modeling (FEA) for implant and tissue models, tissue biomechanics, validation of smart technologies (micro and nanotechnologies) evaluation of biomaterials, comprehensive evaluation of materials and biomaterials, clinical evaluation of medical devices, medical technology assessment, safety and performance analyses, forensic engineering, explant analyses of implants and tissue, and failure analyses.
Therapeutic Areas - Orthopedics, Neurosurgical, Dental, Wound care, Gynecological, Biologics, Pain management, Rehabilitative medicine, Urological, Biomaterials, Biomechanics.
consumer products, toys, sports equipment, textiles.
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