QAC

Screw Sleeve Bone Fixation Device

Product code

QAC

Device name

Screw Sleeve Bone Fixation Device

Device class

Class 2

21 CFR

21 CFR 888.3043

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

FDA classification definition

A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.

Definition text from the FDA device classification database (U.S. federal government work, public domain).