Spinal Channeling Instrument, Vertebroplasty

OCJ · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.4540

Classification

FDA Product Code: OCJ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 888.4540
Review panel: OR
Medical specialty: Orthopedic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 48

Source

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