Product code QFP

Device name

Intraoperative Orthopedic Strain Sensor

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3090

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset