510(k) DEN220015
DEN220015 is an FDA 510(k) premarket notification submitted by Orthobond Coporation for the device "Orthobond Mariner Pedicle Screw System". The FDA issued a decision of De Novo Granted on April 5, 2024. The device falls under product code QZY (Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating), a Class II device regulated under 21 CFR 888.3071.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 5, 2024
- Date Received
- February 28, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
- Device Class
- Class II
- Regulation Number
- 888.3071
- Review Panel
- OR
- Submission Type
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.