FDA-Device2018-02-21Class II
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
OrthoPediatrics Corp
Hazard
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Sold states
US Nationwide Distribution
Affected count
24 units
Manufactured in
2850 Frontier Dr, Warsaw, IN, United States
Products
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2018Don't want to check this manually?
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