MEDINAUT KYPHOPLASTY SYSTEM— 510(k) K133669

Substantially Equivalent

Imedicom

FDA 510(k) clearance K133669 for MEDINAUT KYPHOPLASTY SYSTEM, Substantially Equivalent on 2014-04-04. Applicant: Imedicom.

Clearance details

Applicant: Imedicom
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2013-11-29
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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