LBM · Porous Polyethylene Ossicular Replacement
Ear, Nose, Throat · 21 CFR 874.3450 · Class 2
Overview
| Product Code | LBM |
|---|---|
| Device Name | Porous Polyethylene Ossicular Replacement |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823442 | FISCH MODIFIED TOTAL OSSICULAR PROSTHES | Treace Medical, Inc. | Dec 3, 1982 | SESE |
| K823441 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Treace Medical, Inc. | Dec 3, 1982 | SESE |
Top Applicants
- Treace Medical, Inc. — 2 clearances
