NJA — Accessory, System, External Fixator, Containing Antimicrobial Agent Class II
FDA product code NJA covers "Accessory, System, External Fixator, Containing Antimicrobial Agent", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- NJA
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.