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U.S. Department of Health and Human Services

Product Classification

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Device orthopaedic surgical planning and instrument guides
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Physical State Software and hardware
Technical Method for pre-surgical planning including transfering, visualizing, measuring, annotating and editing medical data. Patient specific templates that are based on pre-operative plan and are designed to fit a specific patient. These guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.
Target Area long bones
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePBF
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible