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Screw Sleeve Bone Fixation Device, Spine

FDA product code QVI · 2 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3043
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-02-27 – 2023-10-26

A spinal 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.

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