FDA-Device2015-04-29Class II
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
SpineFrontier, Inc.
Hazard
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Sold states
US Nationwide Distribution in the states of TX, KS, CO, and MA
Affected count
5 devices
Manufactured in
500 Cummings Ctr Ste 3500, Beverly, MA, United States
Products
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2015Don't want to check this manually?
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