DeviceClearance

Product code NDN— Orthopedic

ARCUATE VERTEBRAL AUGMENTATION SYSTEM

Classification name
Cement, Bone, Vertebroplasty
Device class
Class 2
Regulation
21 CFR 888.3027
Advisory panel
Orthopedic
Total cleared
108
First cleared
Most recent

Market context for product code NDN

FDA has cleared 108 devices under product code NDN between 2004 and 2026, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NDN

Adverse events under product code NDN

product code NDN
Death
24
Injury
407
Malfunction
1,975
Total
2,406

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NDN

1–100 of 108

Data sourced from openFDA. This site is unofficial and independent of the FDA.