# LZN: Cement Obturator

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 59 days (middle half 59–59)
- Recalls: 1 (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)
- 1995: 5
- 1996: 3
- 1997: 2
- 1999: 1
- 2000: 2
- 2001: 2
- 2002: 1
- 2003: 1
- 2006: 1
- 2022: 1

## Most-cited predicates
- K791125: Plug-Lok Cement Restirctor (1979), cited by 5
- K220838: Artisan Bone Plug, Universal Cement Restrictor (2022), cited by 2
- K000587: Shuttle Stop (2000), cited by 2
- K943727: Biostop G Bone Cement Restrictor (1995), cited by 2
- K011943: Impro Vise Absorbable Cement Flow Restrictor (2001), cited by 2
- K933077: Exeter Intramedullary Bone Plug (1995), cited by 2
- K951860: Howmedice Bone Plug (1995), cited by 2
- K830949: Polyethylene Medullary Plug - Stiihmer/ (1983), cited by 2
- K920118: Resorabplug (1993), cited by 1
- K951930: Cementralizer Distal Stem Centralizer (1995), cited by 1

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