Intervertebral Fusion Device With Integrated Fixation, Lumbar

OVD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3080

Classification

FDA Product Code: OVD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3080
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Market data

Cleared 510(k) submissions: 198
Registered establishments: 255

Source

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