# K013257: Hemi-Arc Surgical Navigator

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Oct 30, 2001 after 29 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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. The FDA summary names its predicate without a number.
- (no number) Surgical Guide Frame: named in the summary without a submission number

## Indications for use
The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.

Source page: https://510kreport.com/device/K013257
Methodology: https://510kreport.com/methodology