FDA product code QFP

Intraoperative Orthopedic Strain Sensor

Orthopedic·Class 2·21 CFR 888.3090
US regulatory classifications
US Product Code (FDA)
QFP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3090
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Intraoperative Orthopedic Strain Sensor is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.