FITBONE TAA— 510(k) K163368

Substantially Equivalent

Wittenstein Intens GmbH

FDA 510(k) clearance K163368 for FITBONE TAA, Substantially Equivalent on 2017-01-26. Applicant: Wittenstein Intens GmbH.

Clearance details

Applicant: Wittenstein Intens GmbH
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2016-11-30
Decision date: 2017-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Igersheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.