Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

OJB · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3060

Classification

FDA Product Code: OJB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3060
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 4

Source

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