Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
QRR · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3046
Classification
FDA Product Code
QRR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3046
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.