Product Code: QZY FDA class 2 21 CFR 888.3071

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

Orthopedic

The spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating (product code QZY) is a Class 2 Orthopedic implantable device (regulation 888.3071) consisting of a rigid metallic implant system of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients, with an antimicrobial-surface coating intended to reduce microbial contamination on the device surface prior to implantation. Requiring 510(k) clearance, the device does not contain antimicrobial agents that act within or on the body. It is classified as an implant but is not life-sustaining.

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Basic Information

Product Code: QZY
Device Class: FDA class 2
Regulation Number: 888.3071
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.