MORRISTOWN, N.J., June 4, 2014 /PRNewswire/ -- Tyber Medical, a privately held medical device company focused on developing innovative orthopaedic and spine devices for private label opportunities, announces FDA 510(k) clearance for their headless cannulated trauma screw system.
Tyber Medical's private label customers will now be able to choose from the industry's broadest range of trauma screw sizes (1.5mm – 9.0mm in diameter). These screws are indicated for use throughout the human body in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation.
"Headless screws are ideal for reducing comminuted fractures to fewer fragments before plating. I use headless compression screws for a variety of conditions from arthrodesis to fracture repair," commented Dr. John J. Faillace, orthopaedic hand surgeon and President at Waco Hand, Elbow & Wrist in Waco, TX. "The Tyber Medical trauma screw system is designed to fit all these applications in a single platform."
The Tyber Medical headless compression screw features a titanium or stainless steel body with short, long or full threads packaged either sterile or non-sterile. The screws are self-drilling and self-tapping and are offered with either Torx or hex connection.
"This 510(k) clearance adds over 9,000 devices to our growing product portfolio," said Stu Shank, Tyber Medical Sales Manager. "Tyber Medical's broad selection will allow our customers to differentiate themselves by offering the correct screw size for each indication."
About Tyber Medical, LLC
Tyber Medical, LLC, Morristown, New Jersey, a private label original equipment manufacturer (OEM), is creating new pathways to regulatory approved implants and instruments for orthopaedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopaedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510(k)) and OUS (CE Mark) regulatory approvals. Headless compression trauma screws are the latest addition to a product portfolio which already includes a full line of spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK™, a proprietary titanium plasma sprayed PEEK. For more information, please visit www.tybermedical.com.
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960
SOURCE Tyber Medical, LLC