DeviceClearance

Product code QRR— Orthopedic

CERAMENT G

Classification name
Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Device class
Class 2
Regulation
21 CFR 888.3046
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRR under 21 CFR 888.3046, via openFDA

Market context for product code QRR

FDA has cleared 2 devices under product code QRR between 2022 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRR

Recent clearances under product code QRR

Data sourced from openFDA. This site is unofficial and independent of the FDA.