FDAnews Device Daily Bulletin

SpineNet Fields Warning Over Lack of Acceptance Activities

Aug. 5, 2013
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SpineNet, the specification developer of the SpineNet anterior cervical cage (ACC) system, did not establish acceptance activities for its incoming inspections of components, finished implants and returned goods, according to a recent FDA warning letter. The Winter Park, Fla., company told an FDA investigator that the SpineNet ACC implant has teeth to prevent it from moving in the body, but SpineNet does not inspect the teeth on incoming finished implants from the contract manufacturer.
The GMP Letter