Product code NJA

Device name

Accessory, System, External Fixator, Containing Antimicrobial Agent

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3040

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset