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 Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Unknown
The Solid-Sphere Lumbar Intervertebral Fusion Device with Bone Graft is a spinal implant intended to be inserted between vertebral bodies in the disc space from L3 to S1 to provide stabilization and promote intervertebral body fusion, used with bone graft and not intended for motion-sparing or non-fusion procedures. The device is classified per the Federal Register at 2023-06566. As an FDA Class 3 device requiring Premarket Approval (PMA), it is reviewed by the Orthopedic panel with product code NVR. The device is flagged as an implant given its permanent surgical placement in the lumbar spine.
510(k) Clearances
6 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.