QZY — Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating Class II
FDA product code QZY covers "Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating", a Class II medical device regulated under 21 CFR 888.3071. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QZY
- Device Class
- Class II
- Regulation Number
- 888.3071
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220015 | orthobond coporation | Orthobond Mariner Pedicle Screw System | April 5, 2024 |