# K032476: Nuvasive Mesh

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Nov 13, 2003 after 93 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
753 later devices descend from it; 6 cite it directly.
0 of 754 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NuVasive Mesh: named in the summary without a submission number

## Most influential descendants
- K043405: Nuvasive Coroent System (2005), 712 descendants of its own
- K051454: Aleutian Spacer System (2005), 666 descendants of its own
- K063399: Aleutian Spacer System (2007), 663 descendants of its own
- K082698: Aleutian Ibf System (2009), 662 descendants of its own
- K101302: Aleutian Ibf System (2010), 595 descendants of its own

## Indications for use
The NuVasive' Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasiveO Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K032476
Methodology: https://510kreport.com/methodology