FDA product code · Orthopedic

Vertebroplasty Compound, Calcium Based

Name: FDA decisions, review times, recalls and adverse event reports for product code NUD
Creator: 510(k) Report

NUDClass II21 CFR 888.3027510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of NUD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NUD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NUD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 888.3027.

OBL Cement, Bone, Pre-Formed, Modular, Polymeric…PML Bone Cement, Posterior Screw Augmentation LOD Bone Cement NDN Cement, Bone, Vertebroplasty MBB Bone Cement, Antibiotic OBM Cement, Bone, Vertebroplasty, Pre-Formed…