FDA approves additional clearance for Captiva Spine MIS pedicle screw system
Captiva Spine Inc. recently announced it received 510(k) clearance from the FDA for larger diameter screws within their TowerLOX MIS Pedicle Screw System and CapLOX II Pedicle Screw System.
The company noted the systems will now include 8.5-mm and 9-mm polyaxial screws (non-cannulated, cannulated and reduction) for minimally invasive surgery, mini-open and open cases in 30-mm to 100-mm lengths. The systems will still maintain the same instrument compatibilities, according to a press release from the company.
“We are pleased to know that after successfully supporting over 5,000 surgeries with Captiva Spine pedicle screws, that surgeons have come to know our company as providing thoughtful and elegant systems combined with reliable solutions for the growing and diverse clinical needs in spine care,” Dale Mitchell, president and founder of Captiva Spine, said in the release.