QFP

Intraoperative Orthopedic Strain Sensor

Product code: QFP
Device name: Intraoperative Orthopedic Strain Sensor
Device class: Class 2
21 CFR: 21 CFR 888.3090
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification 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.

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

Official FDA classification page: QFP

Classification and pathway per current FDA publications. Data from openFDA (CC0).