FDA product code · Orthopedic
Prosthesis, Spinous Process Spacer/Plate
4 FDA decisions since 2005. 4 recalls name this code, 0 of them Class I.
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NQO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NQO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQO
Too few NQO 510(k)s in any year since 2007 to give a median.
Recalls per year · NQO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQO
759in 2025
MAUDE reports naming product code NQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | — | 0 | 19 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | — | 0 | 205 |
| 2010 | 3 | — | 0 | 127 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 64 |
| 2014 | 2 | — | 0 | 42 |
| 2015 | 5 | — | 0 | 33 |
| 2016 | 4 | — | 0 | 31 |
| 2017 | 5 | — | 0 | 34 |
| 2018 | 9 | — | 0 | 17 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 10 | — | 0 | 206 |
| 2021 | 3 | — | 0 | 474 |
| 2022 | 2 | — | 1 | 345 |
| 2023 | 2 | — | 0 | 250 |
| 2024 | 3 | — | 0 | 159 |
| 2025 | 1 | — | 0 | 759 |
| 2026 | 2 | — | 0 | — |
Planning a device in NQO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report