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.
Spinal Fixation System
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The Spinal Fixation System is an orthopedic implant device used for stabilization of the posterior thoracic and lumbar spine, typically consisting of rods, screws, hooks, and connecting elements that are surgically implanted to provide rigid fixation of vertebral segments in conditions such as spinal deformity, fracture, or degenerative disease. It is currently unclassified (device class N) with no regulation number assigned, reviewed under the Orthopedic panel. It is flagged as an implant, reflecting its use as a permanently implanted spinal stabilization construct. Unclassified devices require a De Novo or 510(k) determination before marketing in the US.
No 510(k) clearances found for "PWG". Try a different K-number, product code, or device name.
What 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.