HAPES MALLEABLE INCUS STAPES
Device Facts
| Record ID | K950984 |
|---|---|
| Device Name | HAPES MALLEABLE INCUS STAPES |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | ETB · Ear, Nose, Throat |
| Decision Date | Mar 15, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3450 |
| Device Class | Class 2 |
Regulatory Classification
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.
