| Device |
spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating |
| 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. |
| Physical State |
Spinal fusion system with one or more rigid metallic implants with a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating. |
| Technical Method |
The metallic implant provides immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is intended to reduce microbial contamination on the surface of the device prior to implantation. |
| Target Area |
Spine |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QZY |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3071
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
