FDA-Device2018-03-21Class II
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Hazard
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Sold states
US Nationwide Distribution
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1072-2018Don't want to check this manually?
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