510(k) Report

FDA product code · Orthopedic

Intervertebral Body Graft Containment Device

OQBClass II21 CFR 888.3085510(k) required4 decisions since 20200 recalls

4 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 212 days (half between 168 and 222). No recall names this code. The most-cited predicate is DEN200010, named by 1 later device.

An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of OQB 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 · OQB

1in 2025

2020: 12023: 22025: 1
2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQB

Too few OQB 510(k)s in any year since 2007 to give a median.

Recalls per year · OQB

No recall names OQB since 2007.

Adverse event reports per year · OQB

10in 2025

2021: 12022: 22023: 72024: 62025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code OQB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—01
20220—02
20232—07
20240—06
20251—010
20260—0—
FIG. 1 — OQB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OQB? 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