# K092531: SPINE360 Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spine360
- Decided: Feb 4, 2010 after 170 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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.
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) Synthes CSLP: named in the summary without a submission number

## Recalls of this device
- Nov 13, 2017 · Class II · Z-0239-2018: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.

## Indications for use
The Spine36O Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications: *Degenerative disc disease [DOD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies *Spondylolisthesis *Spinal Stenosis *Tumors *Trauma (i.e. fracture)

Source page: https://510kreport.com/device/K092531
Methodology: https://510kreport.com/methodology