NJA

Accessory, System, External Fixator, Containing Antimicrobial Agent

Product code: NJA
Device name: Accessory, System, External Fixator, Containing Antimicrobial Agent
Device class: Class 2
21 CFR: 21 CFR 888.3040
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NJA

Classification and pathway per current FDA publications. Data from openFDA (CC0).