DeviceClearance

Product code QFP— Orthopedic

LOADPRO™ Intraoperative Rod Strain Sensor

Classification name
Intraoperative Orthopedic Strain Sensor
Device class
Class 2
Regulation
21 CFR 888.3090
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QFP under 21 CFR 888.3090, via openFDA

Market context for product code QFP

FDA has cleared 1 device under product code QFP, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QFP

Recent clearances under product code QFP

Data sourced from openFDA. This site is unofficial and independent of the FDA.