Accessory, System, External Fixator, Containing Antimicrobial Agent

NJA · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3040

Classification

FDA Product Code: NJA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3040
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown