PANAMA ANTERIOR CERVICAL PLATE SYSTEM (PACS)

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.

IMPLANTS

Self-Drilling Variable Screws
Self-Tapping Fixed Screws
1-5 level cervical plates
The Flospine PANAMA™ Anterior Cervical Plate (ACP) System consists:
  • Cervical Plates for 1-5 Level fusion, with varying lengths at each level.
  • Fixed and variable angle screws available in 4.0mm and 4.5mm diameters with the overall lengths from 12mm to 20mm and two types: tapping and self-drilling screws.
  • Screws will feature a threaded hole at the bottom of the drive for easy insertion.
  • The reusable instruments for implantation include drivers that interface with the lock, drivers for the screws with threaded inserter through the driver, plate benders to contour plates as needed, drills with a physical stop, fixed and variable angle drill guides with a graduated bubble level for easier alignment, awls, a plate holder, calipers for measuring the distance between vertebral endplates to determine the cervical plate length, and a detachable handle for the drills and awls.

INSTRUMENTS

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