FDA Product Code ORY: Tongue Suspension System
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.
Leading manufacturers include Siesta Medical, Inc..
10
Total
10
Cleared
114d
Avg days
2010
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Tongue Suspension System Devices (Product Code ORY)
10 devices
About Product Code ORY - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code ORY since 2010, with 10 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
ORY devices are reviewed by the Dental panel. Browse all Dental devices →