NUD — Vertebroplasty Compound, Calcium Based Class II
FDA product code NUD covers "Vertebroplasty Compound, Calcium Based", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- NUD
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.