Ackermann Intervertebral Body Fusion Device— 510(k) K143450

Substantially Equivalent

Ackermann Instrumente GmbH

FDA 510(k) clearance K143450 for Ackermann Intervertebral Body Fusion Device, Substantially Equivalent on 2015-09-16. Applicant: Ackermann Instrumente GmbH.

Clearance details

Applicant: Ackermann Instrumente GmbH
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-12-02
Decision date: 2015-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rietheim, Weilheim, DE

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.