Tyber Medical Expands FDA 510(k) Clearance Of Headed And Snap-Off Screws
MORRISTOWN, N.J., June 14, 2016 /PRNewswire/ -- Tyber Medical, LLC, a company focused on providing rapid private label commercialization with innovative orthopedic and spine devices including bioengineered surfaces, announces FDA 510K clearance of their headed and snap-off screws systems.
Tyber Medical's private label partners now have access to the most extensive range of trauma screws on the market today. The addition of the cannulated headed screws (available in 1.5mm-9.0mm) and snap-off screw (available 1.5mm-3.0mm) complements the already successful headless trauma screw. Included within Tyber Medical's 510(k) clearance, are screw configurations incorporating the company's proprietary BioTy modified surface treatment.
These screws are indicated for use throughout the extremities in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device. The headed and headless screw systems are immediately available to private label partners.
"The team worked diligently with our surgeon advisors to simplify, optimize and perfect the screw system for ease of use while delivering a low profile option to their customers." commented Eric J. Dickson, Global Director of Business Development, Tyber Medical. "Tyber Medical's private label partners now have the ability to incorporate the headless, headed, and snap-off screws in one tray configuration for their customers. This reduces the amount of tray inventory required and adds convenience for the surgeon through multiple implant options in one tray."
The clearance of headed and snap-off screws completes an entire trauma screw system available only through Tyber Medical's successful comprehensive portfolio of CE Marked and FDA approved private labeled implants. Tyber Medical's portfolio now includes over 46,000 different product configurations contained across 39 different product lines. All of these technologies are available through Tyber Medical private label partnerships.
About Tyber Medical:
Tyber Medical, LLC, Morristown, New Jersey, a rapid commercialization device company, is creating new pathways to regulatory approved bioengineered implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include the opening osteotomy system, headless and headed compression screws, snap-off screws, cervical plating system, lateral retractor system and spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK®, a proprietary titanium plasma sprayed PEEK. The company is also developing BioTy, a nanotopography surface modification which limits the adherence of bacteria to implants. For more information, please visit www.tybermedical.com.
The TyWedge System and Spinal Interbody Spacers are made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions.
Eric J. Dickson
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960
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SOURCE Tyber Medical, LLC