Injector, Vertebroplasty (Does Not Contain Cement)

OAR · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.4200

Classification

FDA Product Code: OAR
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 888.4200
Review panel: OR
Medical specialty: Orthopedic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Market data

Cleared 510(k) submissions: 1
Registered establishments: 69

Source

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