# K061934: XTAC

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics, Inc.
- Decided: Jul 17, 2007 after 375 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The XTAC is indicated for the temporary bridging of fascial defects where primary closure is not possible, including, but not limited to, abdominal compartment syndrome.

Source page: https://510kreport.com/device/K061934
Methodology: https://510kreport.com/methodology