# K213813: DuraFuse Clip and Applier System

- Pathway: 510(k) (Traditional)
- Applicant: Neuramedica, Inc.
- Decided: Jul 22, 2022 after 227 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933887 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962043: Auto Suture Modified VCS Clip Applier, United States Surgical, A Division of Tyco Healthc (1996) Summary page 4.

## Indications for use
DuraFuse Clips are indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura mater in neurosurgical and orthopedic spine procedures.

Source page: https://510kreport.com/device/K213813
Methodology: https://510kreport.com/methodology