21 CFR 888.3071 — Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3071
Identification
A spinal fusion device with quaternary ammonium coating is a rigid metallic implant device or system comprised of single or multiple components intended to facilitate fusion in skeletally mature patients. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is 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 and this device type does not include combination products.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZY | Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating | 2 | 1 | Implant |
Special Controls
QZY — Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
In combination with the general controls of the FD&C Act, the spinal fusion device with quaternary ammonium compound coating is subject to the following special controls:
De Novo Order DEN220015
