ARCUATE VERTEBRAL AUGMENTATION SYSTEM— 510(k) K070527

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K070527 for ARCUATE VERTEBRAL AUGMENTATION SYSTEM, Substantially Equivalent on 2007-05-04. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2007-02-23
Decision date: 2007-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.