# MNH: Orthosis, Spondylolisthesis Spinal Fixation

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 309
- Recalls: 11 (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)
- 2007: 5
- 2008: 13
- 2009: 13
- 2010: 10
- 2011: 17
- 2012: 7
- 2013: 10
- 2014: 12
- 2015: 10
- 2016: 8

## Most-cited predicates
- K031585: U&I, Optima, Spinal System (2003), cited by 41
- K950099: Synergy (TM) TI Posterior Spinal System (1997), cited by 35
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), cited by 23
- K992739: Click'x (2000), cited by 21
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems (1998), cited by 20
- K062174: Modification to Expedium Spine System (2006), cited by 19
- K001668: Global Spinal Fixation System (2000), cited by 16
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation (1995), cited by 16
- K940631: Cross Medical - Synergy (TM) Spine System (1995), cited by 16
- K951725: Osteonics Spinal System (1995), cited by 16

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