SeaSpine Holdings (SPNE) Reports FDA 510(k) Clearance for Mariner Posterior Fixation System
- Wall Street again marks new highs in post-election run
- Broadcom Ltd. (AVGO) Tops Q4 EPS by 11c
- Restoration Hardware (RH) Tops Q3 EPS by 4c; Guides Well Below the Street
- Unusual 11 Mid-Day Movers 12/8: (COOL) (TLRD) (DRAM) Higher; (SHIP) (OHRP) (MLSS) Lower
- After-Hours Stock Movers 12/08: (FNSR) (AVGO) (GLPG) Higher; (XTLY) (RH) (DLTH) Lower (more...)
Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.
SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Mariner™ Posterior Fixation System.
The Mariner Posterior Fixation System is a pedicle screw system featuring modular threaded technology and accompanying instrumentation. Designed to reduce the number of trays needed for surgery, Mariner is intended to provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation. Key market differentiators of the Mariner System include in-situ modularity, motion limiting heads and rod versatility with both 5.5mm and 6.0mm offerings.
“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” stated Douglas Orndorff, MD. “Mariner is versatile, yet simple to use. Ultimately, it lets me make intraoperative decisions seamlessly.”
Dr. Warren Yu, Director of Spine Surgery at George Washington Hospital commented, “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice – from basic degenerative to complex deformity cases.”
SeaSpine is conducting initial cases with the Mariner Posterior Fixation System through a limited launch that will continue over the coming months. The Company expects a full commercial launch of the Mariner System in the first half of 2017.
“The Mariner Poster Fixation System brings innovative features to the market and utilizes a modular design that increases surgeon flexibility while reducing the number of trays that need to be brought into the operating room,” stated Keith Valentine, Chief Executive Officer of SeaSpine. “The Mariner launch is an important enhancement to SeaSpine’s spinal hardware product offerings in the $1.8 billion posterior lumbar fixation market.”
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Galapagos NV (GLPG) Commences Dosing in SELECTION Phase 2b/3; Milestone Payment Triggered
- William Rhoda Joins SeaSpine as General Manager of Process Innovation and Development
- Valeant Pharma (VRX) Announces Positive Results from IDP-118 Phase 3 as Psoriasis Treatment
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!