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Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville TX 75056 May 11 2017 Re K170647 Trade/Device Name Connector System Regulatory Class Unclassified Product Code NKG KWP NKB KWQ Dated March 2 2017 Received March 3 2017 Dear Ms. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 3070 21 CFR 888. 3050 and 21 CFR 888. 3060 Review Panel Orthopedic Device...
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Orthofix Inc is a medical device company that provides orthopedic products for bone and joint disorders.
Orthofix Inc is required to file regulatory documents with the relevant governing bodies in the healthcare and medical device industry.
Orthofix Inc must fill out the regulatory documents accurately and completely according to the guidelines provided by the governing bodies.
The purpose of Orthofix Inc is to provide innovative orthopedic products and solutions to improve patient outcomes.
The information that must be reported on Orthofix Inc includes financial statements, product information, regulatory compliance, and other relevant data.
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