Easy Global Training Entered an Agreement with Johnson & Johnson to Support Their Clinical Evaluation Review Updates to Become Compliant with MEDDEV 2.7.1 Rev 4

As of Aug 22, 2016, Easy Global Training entered an agreement with Johnson & Johnson to Support Their Clinical Evaluation Review Updates for their Orthopedics devices to become compliant with MEDDEV 2.7.1 Rev 4 for European Union market authorization.

The MOUNTAINEER Laminoplasty System is an implant system that consists of screws and various sizes of plates to address the needs of the surgeon and patient as necessary. Per its Information For Use document (IFU), “the MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures.” “The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.” “Laminoplasties are done to treat the following conditions (Pohl, 2015; O’Brien, 1996; Yonenobu and Oda, 2003):

  • Ossification of the posterior longitudinal ligament (OPLL) over multiple levels with maintained cervical lordosis
  • Congenital canal stenosis with maintained cervical lordosis
  • Multilevel cervical spondylosis with maintained cervical lordosis
  • Posterior compression from ligamentous hypertrophy with maintained cervical lordosis.”

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