FDA-Device2020-07-15Class II
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations LLC
Hazard
Lack of pouch seal. Product is labelled as sterile.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.
Affected count
1965 screws (packaged into 393 boxes) - [5 screw per box]
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2527-2020Don't want to check this manually?
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