FDA-Device2013-07-10Class II
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
SpineFrontier, Inc.
Hazard
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
Sold states
USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
Affected count
12 devices
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2013Don't want to check this manually?
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