# K081377: Nuvasive Surgical Mesh System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Jan 15, 2009 after 244 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
Longest line of descent: 1 generation back to K053215 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053215: Surgical Mesh System, Nuvasive, Inc. (2006) Summary page 1.

## Indications for use
The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

Source page: https://510kreport.com/device/K081377
Methodology: https://510kreport.com/methodology