Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
The Bone Void Filler, Calcium Compound Containing Single Approved Aminoglycoside is a resorbable calcium salt implant designed to fill bony defects in the extremities where there is an elevated risk of infection, particularly for reduction of recurrence of chronic osteomyelitis of long bones. The device is intended to resorb over time and be replaced by new bone; it is not intended to treat active infection. Classified as FDA Class 2 under regulation 888.3046, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. It is not life-sustaining.
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Basic Information
- Product Code
- QRR
- Device Class
- FDA class 2
- Regulation Number
- 888.3046
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.