FDA-Device2016-09-14Class II
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Biomet Microfixation, LLC
Hazard
Potential sterility deficiency.
Sold states
Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.
Affected count
54 units
Manufactured in
1520 Tradeport Dr, Jacksonville, FL, United States
Products
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2751-2016Don't want to check this manually?
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