# K946258: Model 8000 Atlas C-1 Orthogonal Adjusting Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Spinalight, Inc.
- Decided: Nov 20, 1995 after 349 days
- Product code: LXM (Manipulator, Plunger-Like Joint)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K172536: Atlas Percussion Adjusting Instrument (2018), 0 descendants of its own

## Recalls of this device
- Mar 6, 2013 · Class II · Z-1809-2013: Unapproved medical device

Source page: https://510kreport.com/device/K946258
Methodology: https://510kreport.com/methodology