510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Intervertebral Body Graft Containment Device
Orthopedic
The Intervertebral Body Graft Containment Device (product code OQB) is a non-rigid implanted spinal device designed to contain bone graft material within an internal cavity. It is inserted into the intervertebral body space of the spine and functions as an adjunct to intervertebral body fusion procedures. As an FDA Class 2 orthopedic device under regulation 888.3085, it requires 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. This device is flagged as an implant, meaning it is placed inside the body, though it is not life-sustaining. It falls within the Orthopedic medical specialty.
510(k) Clearances
4 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.