QRR — Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside Class II

FDA Device Classification

Classification Details

Product Code
QRR
Device Class
Class II
Regulation Number
888.3046
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K234008bonesupportCERAMENT GMarch 13, 2024
DEN210044bonesupportCERAMENT GMay 17, 2022