# K162647: NuVasive NuvaLine Mobile App

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: May 1, 2017 after 221 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K842956 (1984). 86 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 4.
- K152942: NuVasiveNVM5 System, Nu Vasive, Incorporated (2016) Summary page 4.

## Most influential descendants
- K211987: ATEC Alignment App (2021), 2 descendants of its own
- K240199: IntraOp Alignment System (2024), 1 descendant of its own
- K253216: IntraOp Alignment System; CONTOUR3D Bending System (2026), 0 descendants of its own
- K192435: NuVasive NuvaLine (2019), 0 descendants of its own

## Indications for use
The NuVasive NuvaLine Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, measuring, and storing spinal alignment assessment images at various time points in patient care. The device allows the healthcare professional to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on their mobile device.

Source page: https://510kreport.com/device/K162647
Methodology: https://510kreport.com/methodology