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U.S. Department of Health and Human Services

Product Classification
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Device intraoperative orthopedic strain sensor
Regulation Description Intraoperative orthopedic strain sensor.
Definition A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.
Physical State The device is a strain gauge and associated reader and display instruments.
Technical Method The sensor measures strain on the implant via a strain gauge and provides the output reading on a display.
Target Area Bone
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQFP
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3090
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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