UDI Introduction You may or may not be aware, as of September 24, 2016 the FDA is requiring a unique numeric or alphanumeric code (Unique Device Identification or UDI) on all labels and packaging for Captiva Spine’s implants. UDI applies to all U.S. industry implantable devices and we intend to make this transition as efficient as possible. […]
Captiva Spine’s MIS Pedicle Screw Systems Receive Additional FDA Clearance for Larger Diameter Pedicle Screws Captiva Spine, Inc., announced today that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for larger diameter screws within their TowerLOX MIS Pedicle Screw System and CapLOX II Pedicle Screw System. The additions to their […]
Captiva Spine’s SmartLOX Cervical Plate System Receives Clearance for Enhanced and Patented Screw Locking Mechanism (SmartLOX™ Cervical Plate System) – Captiva Spine, Inc., a medical device organization dedicated to developing and distributing intelligent and intuitive spine device solutions, announced today it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market an enhanced […]
Captiva Spine’s TowerLOX MIS Pedicle Screw System Receives Clearance for Enhanced Rod Insertion and Reduction Captiva Spine, Inc., a medical device organization dedicated to creating and maintaining sincere, honest, collaborative relationships to deliver smart, elegant, and intuitive spinal solutions, announced today it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to […]
