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U.S. Department of Health and Human Services

Product Classification
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Device bone indentation device
Regulation Description Bone indentation device.
Definition A bone indentation device is a device that measures resistance to indentation in bone.
Physical State Main device is a hand-held reusable stylus with single-use patient-contacting tip. Device includes electronics, laptop, and plastic resins.
Technical Method The devices makes a puncture wound through skin and periosteum, and makes multiple indentations directly into the tibia.
Target Area Mid-point on the left or right anterior tibia.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQGQ
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.1600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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