QVIClass II

Screw Sleeve Bone Fixation Device, Spine

21 CFR 888.3043 / Orthopedic

QVI is the FDA product code for Screw Sleeve Bone Fixation Device, Spine, a class II device type, regulated under 21 CFR 888.3043. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2023-10-26, and no recalls.

Classification record

Product code: QVI
Device name: Screw Sleeve Bone Fixation Device, Spine
FDA definition: 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.
Regulation: 21 CFR 888.3043
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code QVI

By decision year

2 clearances under product code QVI with a decision year between 2023 and 2023, 2023 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code QVI by decision year
Year	Clearances
2023	2

Applicants with the most clearances

Product code QVI

Applicants holding the most 510(k) clearances under product code QVI
Applicant	Clearances
woven Orthopedic Technologies	2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QVI

Recent recalls

Product code QVI

FDA records show no recalls under product code QVI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)