ChoiceSpine Gains FDA Clearance for Two Cervical Spinal Fusion Devices

By Julie A. Vetalice

ChoiceSpine received FDA 510(k) clearance to market the TIGER SHARK™ C interbody device with BioBond™ technology and the BOOMERANG™ Anterior Cervical Plate (ACP), for use together or separately in cervical spinal fusion.

BOOMERANG instrumentation is designed to allow simultaneous insertion of the BOOMERANG plate with cervical interbodies, such as TIGER SHARK C or STEALTH™, mimicking a stand-alone ACDF concept and reducing O.R. time. The BOOMERANG ACP features a two-screw configuration and single-step screw blocking mechanism to optimize insertion and fixation.

TIGER SHARK C is a 3D-manufactured titanium alloy interbody created with BioBond organic, porous interbody architecture designed for continuous porosity with an osteoconductive, hydrophilic surface.

ChoiceSpine Tiger Shark, BOOMERANG - ORTHOFLASH

Source: ChoiceSpine

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory