Screw Sleeve Bone Fixation Device, Spine

QVI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3043

Classification

FDA Product Code: QVI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3043
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown