3 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 28, 2015
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·August 21, 2013