Prosthesis, Ear, Internal
An internal ear prosthesis is a surgically implanted device used to restore the cosmetic appearance of the external ear following injury, congenital absence, or surgical removal, typically fashioned from biocompatible materials. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FZD, regulated under 21 CFR 878.3590, within the General, Plastic Surgery medical specialty. This device is designated as an implant.
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Basic Information
- Product Code
- FZD
- Device Class
- FDA class 2
- Regulation Number
- 878.3590
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172389 | ePTFE-Coated Auricular Implant | Jul 18, 2018 | Substantially Equivalent | Implantech Associates, Inc. |
| K863939 | POREX(TM) EAR PROSTHESIS | Oct 24, 1986 | Substantially Equivalent | Porex Medical |
| K844960 | CANAL WALL PROSTHESIS | Feb 26, 1985 | Substantially Equivalent | Richards Medical Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.