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Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA product code QRR · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3046
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-03-13 – 2024-03-13

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.

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