Entries by Captiva Spine

Captiva Spine Announces Alpha Launch of the TransFasten Posterior SI Fusion System

TransFasten™ Posterior SI  Fusion System  Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to creating sincere and collaborative relationships to deliver smart, elegant, and intuitive spine fusion solutions. Today, Captiva Spine is announcing the alpha launch of the TransFasten Posterior SI Fusion System.  The TransFasten Posterior SI Fusion System was developed […]

Captiva Spine Update: First TransFasten Cases; Hired VP Sales; Introducing HyperLOX

Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System, Additions of VP of Sales & Business Development and HyperLOX™ Posterior Cervical System Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System; the well-timed addition of […]

Upcoming Deadline for UDI (Unique Device Identification) Compliance

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. […]

MIS Pedicle Screw Systems Receive Additional Clearance For Larger Diameter Pedicle Screws

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 […]

SmartLOX Cervical Plate System Receives Clearance For Enhancements

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 […]

TowerLOX MIS Pedicle Screw System Enhancements Receive Clearance

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 […]