DEN220015 is an FDA 510(k) submission for the Orthobond Mariner Pedicle Screw System. This device is classified as a Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating (Class II - Special Controls, product code QZY).
Submitted by Orthobond Coporation (Monmouth, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3071. 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..
| 510(k) Number | DEN220015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 28, 2022 |
| Decision Date | April 05, 2024 |
| Days to Decision | 767 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QZY - Spinal Fusion System With 12-methacryloyloxydodecyl Pyridinium Bromide (c21h34brno2) Coating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3071 |
| 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. |