QZY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3071
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Orthobond Mariner Pedicle Screw System (DEN220015) | Orthobond Coporation | 2024-04-05 |
Track QZY automatically
Every clearance here is in the API, with alerts when new ones post.