FOR IMMEDIATE RELEASE:
August 7th 2017
FuzeFix Screw System – FDA Cleared
We are pleased to announce the FuzeFix Screw system as the newest addition to the FDA cleared Fusion Orthopedics product offering. FDA 510(k) approval was issued August 7, 2017. The assigned FDA 510(k) # for the FuzeFix Screw System is K170038.
The FuzeFix Screw System consists of:
Headed Compression Screws from 2.0mm to 7.3mm
Headless Compression Screws from 2.0mm to 6.5mm
Fully Threaded Headless Compression Screws from 2.5mm to 4.5mm
Twist Off Screws from 2.0mm to 2.5mm
Together the FuzeFix System offering comprises of 338 implants and 80 instruments.
The screws are cannulated, self-drilling, self-tapping, and utilize a highly anticipated proprietary removal system.