MADE IN TEXAS
February 6, 2012
Eminent Spine shares FDA evaluation results
The Food and Drug Administration has completed an evaluation of Eminent Spine’s corrective actions in response to receiving a warning letter, 2010-DAL-WL-12. Based on the evaluation Eminent Spine has addressed the violations contained in the warning letter.
Eminent Spine shares FDA audit results
Eminent Spine is pleased to release the results of an unscheduled FDA audit performed between February 28-March 4, 2011. The FDA inspection included the following areas:
•a review of training program(s)
•manufacturing and design operations
•manufacturing and design controls
•corrective and preventive actions
•production and process controls
•process validation
•purchasing controls
•device master records
•complaints and recall procedures
The FDA audit concluded there were no deficiencies noted. Eminent Spine currently has nine spine systems approved by the FDA and is expected to release two new spine implants during the fourth quarter of 2011.
Eminent Spine Clinical Trial Successful for King Cobra Anterior Cervical Plate
Written by Laura Miller | September 15, 2011
Eminent Spine is pleased to announce the company has been featured again in “Becker’s Orthopedic, Spine & Pain Management Review”. Eminent Spine, a Georgetown, Texas-based medical device company, has recently released the results of a study of its King Cobra Anterior Cervical Plate in which no patients experienced complications, according to an Eminent Spine news release.
In the study, surgeons implanted more than 25 patients with 31 of the King Cobra™ plates, and no patient experienced complications. The plates are used with the ES Cervical Interbody Fusion Device, Copperhead® for patients with cervical disc herniation and stenosis.
The King Cobra™ was designed to address problems of cage migration, reduce surgical time and minimize vascular injury. During the study, OR time using the King Cobra™ was 45-210 minutes, with the average time being 110 minutes, and average blood loss was 78cc.
Eminent Spine releases the Anterior Buttress Fang Plate® White Paper
Eminent Spine has released the results of a study of its Anterior Buttress Fang Plate® in which no patient experienced complications. According to a Eminent Spine news release, 39 patients received the Fang Plate®(s) which was used in conjunction with the ES Cottonmouth® Anterior Interbody Fusion Device, for patients with degenerative spondylolisthesis, degenerative disc disease, discogenic pain, lumber disc herniation and stenosis.
A total of 69 Fang Plates® were evaluated. There was no Fang Plate® breakage, no screws backed out and there was no migration of the Cottonmouth®. The TriLobe® locking technology is an effective and safe mechanism to lock the screw into the plate. This study has shown that the Fang Plate® is a safe and effective product. Clinical studies are currently being performed to further evaluate the product.
Eminent Spine releases the Diamondback®Pedicle Screw System and
Boa Constrictor™ Cross-Link White Paper
Eminent Spine has released the results of a study of its Diamondback® Pedicle Screw System and Boa Constrictor™ Cross-Link in which no patients experienced complications. According to a Eminent Spine news release, 72 patients received the Diamondback® Pedicle Screw; bilateral fusion patients also receiving the ES Boa Constrictor™ Cross-Link. 435 Diamondback® Pedicle Screws and 151 Boa Constrictor™ Cross-Link(s) were evaluated. Patients studied had been diagnosed with degenerative spondylolisthesis, degenerative disc disease, discogenic pain, lumber disc herniation, stenosis and scoliosis.
The Diamondback® Pedicle Screw was designed to be self tapping and to simplify insertion is available in a single, double or triple lead thread pitch. The Boa Constrictor™ Cross-Link is offered in 3 different sizes designed for easy implantation and minimizes dura impingement.
This preliminary study has shown that the Diamondback® Pedicle Screw System and the Boa Constrictor™ cross-link system are devices that can be safely implanted. There was no screw breakage, set screw failure, or any implant failure demonstrating the Diamondback® and Boa Constrictor™ are safe and effective products. Clinical studies are currently being performed to further evaluate these products.
Eminent Spine releases the King Cobra™ Anterior Cervical Plate White Paper
Eminent Spine has released the results of a study of its King Cobra™ Anterior Cervical Plate in which no patients experienced complications, according to an Eminent Spine news release.
In the study, surgeons implanted more than 25 patients with 31 of the King Cobra™ plates, and no patient experienced complications. The plates were with the ES Copperhead® Cervical Interbody Fusion Device for patients with cervical disc herniation and stenosis.
This preliminary study has shown no patient experienced plate breakage. There was no migration of the Copperhead®, screw back-out, screw breakage, malfunction of the Twister, infection or dysphagia.
The Eminent Spine Anterior Cervical Plate King Cobra™ is an effective device that can be safely implanted. The Twister locking mechanism has also been shown to be a safe, easy and effective way to lock the screw into the Cervical Plate. Clinical studies are currently being performed to further evaluate the product.
Eminent Spine is featured on: Today in America Copyright © 2011 with Terry Bradshaw
Eminent Spine is pleased to announce the company has earned the interest of those covering the best new practices and overall evolution of so many up and coming industries.
*Click below to view the TIA broadcast report: “Breakthroughs in Medicine Today; the American Industry Series”
January 14, 2011
Eminent Spine receives FDA clearance for the King Cobra™ Cervical Plate
Eminent Spine is pleased to announce the company received 510(k) clearance for the King Cobra™ cervical plate. This is the 8th product the company has received clearance for since 2008. Independent distributors and sales agents experienced in spine are encouraged to contact us for further information.
April 16, 2010
Eminent Spine receives FDA clearance for the Diamondback®Pedicle Screw System
Eminent Spine announced today that the company received 510(k) clearance for the Diamondback® pedicle screw system. The Diamondback® offers: 4.5 - 8.5mm cannulated and non-cannulated screws; fixed and polyaxial heads; single, double and triple lead screws and 5.5mm straight and pre-bent rods. The system also includes the Boa Constrictor low-profile cross link that is available in 3 sizes. Eminent Spine was formed in mid-2008 and this is the 7th spine system that the company has received clearance for in the past year.
June 1, 2009
Eminent Spine receives FDA clearance for the Anterior Lumbar Buttress Fang Plate®
Eminent Spine announced today the receipt of 510(k) market clearance for its anterior lumbar buttress Fang Plate®. The FDA clearance was received June 1, 2009, less than two months after the company's first product clearance for a full line of PEEK spacers. Market clearance for the Diamondback®Pedicle Screw System with Boa Constrictor™ Cross Link and King Cobra™ Anterior Cervical Plate is anticipated in the third and early fourth quarters of this year.
April 9, 2009
Eminent Spine receives FDA clearance for the PEEK Interbody Fusion System
Eminent Spine announced today the receipt of 510(k) market clearance for its full-line PEEK interbody fusion system. The FDA clearance was received April 9, 2009. The Eminent Spine PEEK Interbody fusion system consist of the Texas Sidewinder™ (TLIF), Texas Python™ (PLIF), Cottonmouth® (ALIF), and the Copperhead®(cervical). This is the company's first FDA clearance, with more to follow later this year, including the Anterior Buttress Fang Plate®, The Diamondback®Pedicle Screw System with Boa Constrictor™ Cross link and the King Cobra™ Anterior Cervical Plate.
June 2008
About Eminent Spine
Eminent Spine, co-founded by orthopedic surgeon, Steve Courtney, MD and manufacturing expert, Dave Freehill, is a privately owned company dedicated to developing and manufacturing bio-mechanically sound spinal implants.
