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captiva spine larger diameter pedicle screw

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

Captiva Spine Larger Diameter Pedicle Screw

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 systems include 8.5mm and 9.0mm Polyaxial Screws (non-cannulated, cannulated and reduction) for MIS, Mini-Open and Open cases in 30mm-100mm lengths, while maintaining all of the same instrument compatibilities to the implant. The expansion of Captiva Spine’s line of cannulated and non-cannulated pedicle screws is an example of the company’s promise to continuously provide improvements and enhanced capabilities on behalf of surgeons and patients.

Dale Mitchell, President and Founder of Captiva Spine stated, “We are pleased to know that after successfully supporting over 5000 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.” During the recent introduction of the newest MIS rod inserters, Captiva Spine’s Director of Research and Development, Dennis Ty, said “PivoQuik and PivoRod LP Inserters have been performing as expected, which has resulted in a bigger than expected demand for our reliable rod inserter tools and method.”

In addition to exhibiting at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting this week (March 2-4) in Orlando, FL, Captiva Spine has recently updated their TowerLOX web page to include the system enhancements and a new animation to show the PivoQuik inserter in action (www.captivaspine.com/towerlox). Other additions to their website include information about bioactive glass and their newly distributed product, FIBERGRAFT® BG Morsels and Putty. Inquiries from tenured professionals looking to partner with a company that values integrity, commitment, and collaboration to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

 

This Press Release can be found on PR.com and is also featured with Becker’s Spine, Helio, and Orthopedic Design & Technology.

SmartLOX Cervical Plate and Screws

SmartLOX Cervical Plate System Receives Clearance For Enhancements

SmartLOX Cervical Plate System Header Image and Logo

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 cervical plate system with a patented screw locking mechanism. Their SmartLOX Cervical Plate System incorporates a proprietary Nitinol self-locking mechanism, which provides visual, audible, and tactile confirmation of the cervical screw locking.

Dale Mitchell, President and Founder of Captiva Spine said, “We are especially pleased about this SmartLOX Cervical Plate System FDA clearance, as it incorporates our enhanced screw locking mechanism design. This enhancement allows screws to be inserted sequentially, in tandem or independently while ensuring a reliable and easy to use locking mechanism. While we all know timing is everything, we couldn’t be more excited to also say that this improvement has recently been allowed a patent by the U.S. Patent and Trademark Office.”

The SmartLOX Cervical Plate System has been engineered for ease of use, enhanced control, and predictable performance. In addition to its proprietary self-locking mechanism, SmartLOX Cervical Plate System features large graft/endplate windows for clear visualization, flush/smooth screw head profile, and options for self-tapping, self-drilling, fixed and variable angled screws. Discover more details about SmartLOX™ Cervical Plate System and Captiva Spine’s other high quality and elegant products, such as the Pivotec® TLIF Cage Inserter and TowerLOX® MIS Pedicle Screw System, at their recently re-launched website www.captivaspine.com.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

 


 

 

This Press Release can be found at PR.com and is also featured on Becker’s Spine, and Healio.

TowerLOX MIS System - PivoRod LP and Inserter

TowerLOX MIS Pedicle Screw System Enhancements Receive Clearance

PivoQuik Rod Inserter

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 market its enhanced TowerLOX MIS Pedicle Screw System.

These enhancements to the TowerLOX Pedicle Screw System’s already smooth, reliable and predictable tower system for MIS spine surgery include:

  • PivoQuik™ Rod Inserter (patent pending) and Tower Guide offer simple and quick rod alignment and placement.
  • Modular Open Tower – proprietary locking mechanisms (patent pending) designed to prevent inadvertent tower detachment and allow for rod insertion and visualization through the central shaft of the tower.
  • Reduction Set Screw Driver – allows for rod reduction through the tower without wound expansion while simultaneously driving the set screw thus reducing unnecessary steps.
  • PivoRod LP™ (low profile) – provides efficient rod angle adjustment and “fiddle free” detachment for the inserter.

Captiva Spine continues to add new capabilities to the TowerLOX MIS Pedicle Screw System for surgeons who appreciate controlled, repeatable, and less invasive rod delivery and reduction. Dale Mitchell, President and Founder of Captiva Spine said, “We’ve obsessively invested time collaborating with leading MIS spine surgeons, discovered new resources through our vendor partners, and delivered coordinated enthusiasm through all aspects of this project.” Mitchell also stated that, “During our collaborations with numerous spine surgeons it became very clear that aside from creating a thoughtful and elegant MIS pedicle screw system, it was very important that these enhancements allowed the surgeon to approach challenging surgical situations with confidence.”

Captiva Spine is also excited to present its recently re-designed website www.captivaspine.com, an improved tool for better communication. Inquiries from tenured professionals looking to partner with a company that values integrity, commitment, and collaboration to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.
Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine designs innovative medical and surgical apparatus, appliances, devices and instruments to support spine surgeons, tenured spine distributors, and healthcare facilities.  They strive to provide patients with progressive spinal care devices with an obsessive focus on quality and they create and maintain sincere, honest, collaborative relationships.  Valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of smart, elegant, and intuitive patient solutions.  Captiva Spine consults with clients, providing valuable research information related to the design of surgical devices and instruments. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm. Captiva Spine – Strength Through Connections.

This Press Release can be found at PR.com and is also featured on RYOrtho.comHealio, and Becker’s Spine.