Product code QZY— Orthopedic
Orthobond Mariner Pedicle Screw System
- Classification name
- Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
- Device class
- Class 2
- Regulation
- 21 CFR 888.3071
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QZY
FDA has cleared device under product code QZY, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QZY
Recent clearances under product code QZY
Data sourced from openFDA. This site is unofficial and independent of the FDA.