FDA product code QZY: Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

QZY is the FDA product code for spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating. It is a Class II device, regulated under 21 CFR 888.3071 and reviewed by the Orthopedic panel. Devices under QZY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is a rigid metallic implant system compromised of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The device includes a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body.

Classification

Recalls for QZY devices

openFDA lists no recalls for product code QZY.

Frequently asked questions

What is FDA product code QZY?

QZY is the FDA product code for spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating. It is a Class II device, regulated under 21 CFR 888.3071 and reviewed by the Orthopedic panel.

What device class is QZY?

Class II, regulation 21 CFR 888.3071. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QZY
• Run a recall and safety report across every QZY manufacturer
• Watch product code QZY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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