ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106— 510(k) K080547

Name: FDA 510(k) clearance K080547
Creator: U.S. Food and Drug Administration
Published: 2008-05-23

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K080547 for ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106, Substantially Equivalent on 2008-05-23. Applicant: Aesculap Implant System, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2008-02-28
Decision date: 2008-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.