FDA-Device2025-01-29Class II
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No
Integrity Implants Inc.
Hazard
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Sold states
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Affected count
9
Manufactured in
354 Hiatt Dr, Palm Beach Gardens, FL, United States
Products
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2025Don't want to check this manually?
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