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.
Orthosis, Spine, Plate, Laminoplasty, Metal
Orthopedic
The metal laminoplasty spinal plate orthosis is an orthopedic implant that is surgically attached to the lamina following a laminoplasty or laminectomy procedure to maintain the expanded spinal canal and provide structural support to the posterior spine. It is classified as FDA Class 2 under regulation 888.3050 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag. Product code NQW is not eligible for third-party review.
510(k) Clearances
29 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.