AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM— 510(k) K080992

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K080992 for AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM, Substantially Equivalent on 2008-09-04. Applicant: Aesculap Implant Systems, Inc..

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2008-04-07
Decision date: 2008-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.