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.
| Device Type ID | 1376 |
| Device Name | Prelude Tongue Suspension System |
| Physical State | Bone Screw And Suture Material |
| Technical Method | Physical Advancement Of The Tongue. |
| Target Area | Oral Cavity |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 1376 |
| Device | Prelude Tongue Suspension System |
| Product Code | ORY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| CFR Regulation Number | 872.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SIESTA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 10 |
Fracture | 1 |
| Total Device Problems | 11 |