Tongue Suspension System
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Autocam Medical Devices (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
What Is It?
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.
How Is ORY Classified?
Tongue Suspension System is FDA product code ORY, Class 2, 21 CFR 872.5570.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.