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