ChoiceSpine Gains Additional Clearance for Cervical Spacer

By Julie A. Vetalice

ChoiceSpine Gains Additional Clearance for Cervical Spacer

ChoiceSpine was granted an additional FDA 510(k) clearance for the Tiger Shark Cervical Spacer System.

The titanium alloy-based Tiger Shark C device is constructed into an anatomical form, designed to complement the shape of vertebral bodies. The new 510(k) clearance adds footprint sizes that enhance the ability to treat a wider variety of patient anatomies.

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

"We have had great success with our Tiger Shark C System thus far and we are excited to see where the line extension takes us to support more surgeons and their patients,” said Anderson Collins, Vice President of Business Development and International.

 

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory