FDA product code · Orthopedic
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
3 FDA decisions since 2005. No recall names this code. The most-cited predicate is K051821, named by 1 later device.
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OJB 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 · OJB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OJB
Too few OJB 510(k)s in any year since 2007 to give a median.
Recalls per year · OJB
No recall names OJB since 2007.
Adverse event reports per year · OJB
1in 2015
MAUDE reports naming product code OJB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in OJB? 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) ReportRelated product codes
Other codes under 21 CFR 888.3060.