# MYU: Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

- Device class: 2; regulation: 21 CFR 882.5300; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2000: 1
- 2003: 4

## Most-cited predicates
- K002063: Biotrace, Model 1730 (2000), cited by 2
- K023445: Tracers Bone Cement Opacifier (2003), cited by 1
- K991893: Parallax Tracer Radiopaque Particles (1999), cited by 1

Source page: https://510kreport.com/product-code/MYU
Data by year (CSV): https://510kreport.com/product-code/MYU.csv