Product code QHG

Device name

Defect Measurement Tool

Medical specialty

Orthopedic

Device class

2

Regulation number

888.4510

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset