# LZV: System, Cement Removal Extraction

- Device class: 2; regulation: 21 CFR 888.4580; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1989: 2
- 1990: 2
- 1994: 1
- 1996: 1
- 2002: 1

## Most-cited predicates
- K021502: Oscar, Model OE3000 (2002), cited by 2
- K930629: Acryl-X II System (1994), cited by 1
- K961101: Stryker Cement Removal System (1996), cited by 1

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