UNIVATION— 510(k) K131167

Substantially Equivalent

Aesculap Implant Systems, LLC

FDA 510(k) clearance K131167 for UNIVATION, Substantially Equivalent on 2013-10-17. Applicant: Aesculap Implant Systems, LLC.

Clearance details

Applicant: Aesculap Implant Systems, LLC
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2013-04-24
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.