Tyber Medical Nails 510(k) Clearance for Cannulated Screw System
Tyber Medical said Wednesday it has obtained 510(k) clearance from the FDA to market its headless cannulated trauma screw system.
The Morristown, N.J., devicemaker’s private label customers will now be able to choose among a wide assortment of screws sized 1.5 mm to 9 mm in diameter — a range no other company offers, spokesman Stu Shank tells Devices Daily Bulletin.
The 510(k) clearance adds over 9,000 devices to the company's growing product portfolio, Shank notes. By purchasing from Tyber, customers can “fill the gaps” in their screw offerings without having to go through the regulatory process themselves, he says.
The screws are indicated for use throughout the human body in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, according to the company.
Tyber’s screws have a titanium or stainless steel body with short, long or full threads and come packaged sterile or nonsterile. The self-drilling and self-tapping screws feature either Torx or hex connection, the devicemaker says.
Shank says the company is working on a CE mark submission, but is waiting for the right time to file it. He declined to speculate when that would be. — Kellen Owings
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