510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NJAClass II

Accessory, System, External Fixator, Containing Antimicrobial Agent

21 CFR 888.3040 / Orthopedic
FDA source (opens on fda.gov)

NJA is the FDA product code for Accessory, System, External Fixator, Containing Antimicrobial Agent, a class II device type, regulated under 21 CFR 888.3040. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NJA
Device name
Accessory, System, External Fixator, Containing Antimicrobial Agent
FDA 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.
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NJA.