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.
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Orthopedic
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices are Class 2 orthopedic surgical instruments intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices used in non-fusion spinal procedures. They require 510(k) clearance and are regulated under 21 CFR 888.4520 within the Orthopedic medical specialty. The product code is QLR. The devices are not implants and are not flagged as life-sustaining.
No 510(k) clearances found for "QLR". 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.