# HAX: Tong, Skull For Traction

- Device class: 2; regulation: 21 CFR 882.5960; FDA's rule: 510(k) required
- FDA decisions: 20
- Recalls: 13 (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)
- 1988: 1
- 1992: 1
- 1993: 1
- 1995: 2
- 1999: 1
- 2001: 1
- 2003: 1
- 2005: 1
- 2007: 1
- 2009: 1

## Most-cited predicates
- K834047: PMT-Halo/Orthopedic Jacket System (1984), cited by 2
- K822885: Halo Traction Cervical Immobilization (1982), cited by 1
- K810193: Trippi-Wells Dual Purpose Universal Tong (1981), cited by 1
- K930021: J Tongs (1995), cited by 1
- K023959: Jerome Glass Ring (2003), cited by 1
- K924606: Bremer Imaging Tongs-Mri Model (1993), cited by 1
- K954069: Ace Cervical Traction Halozs, Tongs & Pins (1995), cited by 1

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