Subjects: LIC, FDA
TYBER MEDICAL GAINS FDA AND MDR CLEARANCE FOR ITS IMPLANTABLE K-WIRES AND STEINMANN PINS IN STAINLESS STEEL AND TITANIUM ALLOY
BETHLEHEM, Pa., Sept. 21, 2023 /PRNewswire/ -- Tyber Medical, a leader in the medical device industry, is pleased to announce that it has received:
- FDA and MDR clearance for its implantable K-Wires and Steinmann Pins made from 316L Stainless Steel and Titanium alloy Ti6AL4V ELI.
- MDR clearance for its sterile packed and reusable guide wires and drill bits platform
These critical approvals pave the way for significant expansion and greater product availability for patients and Tyber's private-label partners.
"Our focus has always been on developing products that are innovative, efficient, and deliver unparalleled performance," said Jeff Tyber, CEO of Tyber Medical. "Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand."
The cleared K-Wires and Steinmann Pins are available both Sterile and Non-Sterile and come in multiple configurations, including combinations of Trocar Tip, Diamond Tip, Fluted Tip, Partial Thread, Full Thread, Ball End, and Flat End options, making them versatile for multiple medical needs. Available in lengths ranging from 60mm to 450mm and diameters between 0.6mm and 6.35mm, these wires and pins provide comprehensive solutions for healthcare professionals.
David Hannah, CTO of Tyber Medical, added, "With this clearance, our customers now have instant access to nearly every type of implantable K-Wire or Steinmann Pin that exists on the market, and we're not even finished with this product line yet."
In a strategic move to extend its reach globally, Tyber Medical also obtained a reusable indication for its K-Wires in Europe thanks to its recent acquisition of ADSM-Synchro Medical. This acquisition marked another significant milestone for the company, further bolstering its global presence.
Commenting on the European expansion, Luigi Bivi, President of ADSM SAS (Tyber Medical France), stated, "This development is a key component of our strategic initiative to provide advanced medical solutions worldwide. Tyber Medical's sterile packed reusable platform in Europe enhances our capabilities and allows us to better serve high quality standards while maintaining a cost-effective approach to our product offering."
Tyber Medical continues to innovate and push boundaries in the medical device industry, constantly striving to provide cutting-edge solutions that redefine patient care.
About Tyber Medical
Tyber Medical LLC, is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-enhancing, regulatory-approved orthopedic implants for the spinal, extremity and trauma markets. Tyber Medical provides customers with a quick and seamless path to market. Since it was founded in 2012, the company has released more than 50 spine, extremity, and trauma systems. Tyber Medical aims to develop and utilize differentiated technologies to make advanced orthopedic implants. For more information, visit www.tybermedical.com.
For press inquiries, please contact:
Chandler Kline
Product Manager
717-333-0072
SOURCE Tyber Medical
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