Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments— 510(k) K153700

Substantially Equivalent

Aesculap Implant Systems, LLC

FDA 510(k) clearance K153700 for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments, Substantially Equivalent on 2016-07-08. Applicant: Aesculap Implant Systems, LLC.

Clearance details

Applicant: Aesculap Implant Systems, LLC
Product code: Code OLO
Advisory panel: Neurology
Date received: 2015-12-23
Decision date: 2016-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.