DeviceClearance

Product code QHG— Orthopedic

Barricaid Instrument Tray

Classification name
Defect Measurement Tool
Device class
Class 2
Regulation
21 CFR 888.4510
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QHG under 21 CFR 888.4510, via openFDA

Market context for product code QHG

FDA has cleared 1 device under product code QHG, all in 2020, 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 QHG

Recent clearances under product code QHG

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