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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, calcium compound containing single approved aminoglycoside
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.
Physical State Putty or paste implanted by injection or by hand
Technical Method The resorbable calcium salt bone void filler fills bony defects to allow for new bone formation while the aminoglycoside reduces recurrence of chronic osteomyelitis of long bones.
Target Area Bones of the extremities
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQRR
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3046
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible