FDA Clearance for ChoiceSpine Blackhawk Ti Cervical Spacer

By Julie A. Vetalice

FDA Clearance for ChoiceSpine Blackhawk Ti Cervical Spacer

ChoiceSpine received FDA 510(k) clearance to market the 3D-printed Blackhawk Ti Cervical Spacer.

Blackhawk Ti Cervical includes:

  • BioBond™ 3D-printed titanium porous matrix
  • Large open graft window for bone graft containment & maximum visualization
  • 6° Lordotic and Convex configurations available
  • Simultaneous, single-step anchor deployment
  • External locking indication for easy confirmation of cam-locking mechanism
  • Preassembled integrated anchor technology

Anders Cohen, DO, the Lead Design Surgeon for the Blackhawk Ti system, said, “Blackhawk Ti improves and builds upon the already successful original Blackhawk PEEK device with integrated anchor technology. The addition of 3D-printed porous titanium technology, and the implant’s unique updated design both play a role in the bone growth process during fusion. However, what really sets this system apart from others is the simplicity of the implant design and instrumentation that help to significantly reduce surgery time by decreasing the number of steps in the procedure.”

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance