CERVICAL PLATING
The FloSpine PANAMA™ Anterior Cervical Plate System (ACP) System is designed to provide biomechanical stabilization as an adjunct to fusion in skeletally mature patients. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient’s anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The FloSpine PANAMA™ Anterior Cervical Plate (ACP) System is in the process of 510K submission.
INDICATIONS
The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
