Product code QZY

Device name

Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3071

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset