Vertebroplasty Compound, Calcium Based

NUD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3027

Classification

FDA Product Code: NUD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3027
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

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