QRR

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Product code

QRR

Device name

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Device class

Class 2

21 CFR

21 CFR 888.3046

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

FDA classification definition

A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-03-13.

1 summaries are archived here for direct download.