QHG

Defect Measurement Tool

Product code

QHG

Device name

Defect Measurement Tool

Device class

Class 2

21 CFR

21 CFR 888.4510

Medical specialty

Orthopedic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).