Aesculap Implant Systems, a manufacturer of surgical instruments, has received US Food and Drug Administration (FDA) clearance for its S4 Cervical Occipital Plating System under K100147.
The S4 Cervical Occipital Plating System is used to promote spinal fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) in patients with degenerative disease or fracture.
Aesculap said that the agency began review of the Special 510(k) on 19 January 2010 and has received the Substantial Equivalence determination on 23 July 2010.
Aesculap Implant Systems is formed by the Aesculap company, which will focus on the orthopaedics, spinal implants, neurosurgery and vascular systems and sutures markets, allowing for greater innovation and customer service.
Aesculap Implant Systems maintains a surgeon/patient focus with the goal of improved operative procedures and patient outcomes leading to an improved quality of life.