QRR — Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside Class II
FDA product code QRR covers "Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside", a Class II medical device regulated under 21 CFR 888.3046. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
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.