# HTZ: Instrument, Cutting, Orthopedic

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 21
- Recalls: 23 (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)
- 1977: 3
- 1983: 1
- 1984: 11
- 1985: 3
- 1987: 1
- 1994: 2

## Most-cited predicates
- K933933: Ceboplane (1994), cited by 1

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