# K884884: Ossicular Prosthesis: 8 Partial, 3 Total

- Pathway: 510(k) (Traditional)
- Applicant: Porex Technologies Corp. of Georgia
- Decided: Jun 16, 1989 after 206 days
- Product code: ETA (Replacement, Ossicular Prosthesis, Total)
- Device class: 2
- Regulation: 21 CFR 874.3495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K884884
Methodology: https://510kreport.com/methodology