ORY

Tongue Suspension System

Product code: ORY
Device name: Tongue Suspension System
Device class: Class 2
21 CFR: 21 CFR 872.5570
Medical specialty: Dental
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (all years, FDA): 10 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

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

Official FDA classification page: ORY

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