QHG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Defect Measurement Tool

Device class

Class II (moderate risk)

Regulation

21 CFR 888.4510

Medical specialty

Orthopedic

FDA 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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