# K962377: 3D-Spine

- Pathway: 510(k) (Traditional)
- Applicant: Skill Technologies, Inc.
- Decided: Sep 3, 1996 after 75 days
- Product code: KQX (Goniometer, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 888.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) CA-6000 Spine Motion Analyzer: named in the summary without a submission number
- (no number) CP-2000 Compu-Plotter: named in the summary without a submission number

## Most influential descendants
- K011827: Ortelius 800 (2001), 0 descendants of its own

## Indications for use
3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.

Source page: https://510kreport.com/device/K962377
Methodology: https://510kreport.com/methodology