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U.S. Department of Health and Human Services

Product Classification
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Device bone void filler, syringe
Definition To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis).
Physical State Pre-filled syringe that contains putty composed of bioactive glass particles, polyethylene glycol and glycerol. Syringe tip permits attachment of cannula. Syringe also includes rotating plunger to aid in controlled dispersion of device.
Technical Method Extruded from syringe into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
Target Area Skeletal system (extremities, posterolateral spine and pelvis).
Review Panel Orthopedic
Product CodePBU
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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