LBP · Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
Ear, Nose, Throat · 21 CFR 874.3450 · Class 2
Overview
| Product Code | LBP |
|---|---|
| Device Name | Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material |
| Regulation | 21 CFR 874.3450 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
