FDA product code QHG

Defect Measurement Tool

Orthopedic·Class 2·21 CFR 888.4510
US regulatory classifications
US Product Code (FDA)
QHG
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.4510
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.

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About this record

Defect Measurement Tool 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.