Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

QAD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3023

Classification

FDA Product Code: QAD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3023
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 2

Source

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