FDA-Device2015-01-14Class II
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Ebi, Llc
Hazard
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Sold states
Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
Affected count
2816 approx.units ( 2688 units US and 128 OUS)
Manufactured in
399 Jefferson Rd, N/A, Parsippany, NJ, United States
Products
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2015Don't want to check this manually?
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