FDA-Device2020-08-19Class II
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
Anjon Holdings
Hazard
High rate of galling of one threaded component.
Sold states
Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Affected count
249 devices
Manufactured in
4801 Dawin Rd, N/A, Jacksonville, FL, United States
Products
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2778-2020Don't want to check this manually?
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