Product Classification

• 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 Code: PBF
• Premarket Review: Office of Orthopedic Devices (OHT6); 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible