# K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 20, 1995 after 246 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
692 later devices descend from it; 24 cite it directly.
1 of 693 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (1997), 531 descendants of its own
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System (1999), 313 descendants of its own
- K000486: Abc Cervical Plating System (2000), 289 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own

Source page: https://510kreport.com/device/K945700
Methodology: https://510kreport.com/methodology